PET Radiopharmaceuticals

Discover Cyclotek's comprehensive range of PET radiopharmaceuticals and related services designed to support clinicians, researchers, and healthcare providers.

Oncology Tracers

FDG, PSMA, FES, FET, NaF and novel oncology agents under trial

Neurology Tracers

Amyloid imaging, DAT imaging and tau-related tracer development and supply pathways.

Novel Tracer Development

Advancing molecular imaging through innovation.

PET Tracers – Oncology

¹⁸F-FDG

Oncology · General

PET imaging with 18F FDG provides accurate information about glucose metabolism in normal and abnormal tissues throughout the body. 18F FDG PET can be used to improve healthcare outcomes for a wide range of serious diseases. Greatly increased FDG uptake occurs in most lethal cancers and FDG PET provides unique guidance about the extent, prognosis or response to therapy in many cancer patients. FDG uptake is greatly increased in serious inflammatory conditions but decreased in many degenerative neurological conditions such as Alzheimer’s disease, increasing the scope for FDG PET to improve patient management.

MBS reimbursed

¹⁸F-DCFPyL (PSR)

Oncology · Prostate

PET imaging with ¹⁸F-DCFPyL demonstrates the concentration of PSMA throughout the body. PSMA is a membrane bound receptor protein that is highly expressed in most prostate cancers and particularly in metastastic castrate resistant prostate cancer.

¹⁸F-DCFPyL PET is used to localise cancers in the prostate gland and to detect when pelvic lymph node or distant metastases have occurred.

MBS reimbursed

¹⁸F-Fluoroestradiol (FES)

Oncology · Breast

PET imaging with ¹⁸F-FES demonstrates the concentration of estrogen receptors throughout the body. FES is a close analogue of estradiol which is the major normal substrate for the estrogen receptor. FES has a strong binding affinity to estrogen receptors. Estrogen receptors are overexpressed in many breast cancers and estrogen deprivation therapy is an important treatment at several stages of the disease. FES PET can be used to predict therapeutic response to estrogen deprivation in people with breast cancer.

TGA Special Access Scheme

Authorised Prescriber

Clinical Trials

¹⁸F-Fluoroethyltyrosine (FET)

Oncology · Brain

PET imaging with ¹⁸F-FET provides information about amino acid (protein) metabolism in brain tumours, most of which are characterised by increased FET uptake compared to normal brain.

¹⁸F-FET PET can provide information about the extent, severity or response to treatment in many patients with lethal brain tumours, both primary and secondary.

TGA Special Access Scheme

NZ DHB reimbursed

Authorised Prescriber

Clinical Trials

¹⁸F SODIUM FLUORIDE (NaF)

Oncology · Bone Scan

PET imaging with ¹⁸F NaF provides a highly sensitive method for evaluating bone formation metabolic activity throughout the body.

¹⁸F NaF is a small-molecule that rapidly and directly absorbs to actively accumulating bone matrix. As bone destruction and bone repair are commonly closely coupled, ¹⁸F NaF PET provides a highly sensitive means for detecting many bone pathologies but particularly metastatic disease and trauma.

TGA Special Access Scheme

NZ DHB reimbursed

Authorised Prescriber

Clinical Trials

PET Tracers – Neurology

¹⁸F-Florbetaben (FBB)

Neurology · Amyloid PET

PET imaging with ¹⁸F FBB can demonstrate deposition of β-amyloid proteins throughout the body. A number or serious clinical conditions are characterised by β-amyloid build up in a variety of tissues including the heart, kidneys or brain. β-amyloid accumulates in the brain to form neuritic plaques long before symptoms begin in Alzheimer’s disease.

¹⁸F FBB PET has clinical utility to demonstrate the presence and density of β-amyloid plaques in the brain in patients with suspected dementia.

TGA Special Access Scheme

Authorised Prescriber

Clinical Trials

¹⁸F-PI-2620

Neurology · Tau PET

PET imaging with ¹⁸F PI-2620 can demonstrate deposition of abnormal tau proteins in the brain. Tau has multiple forms and PI-2620 binds most avidly to tau 3R+4R in neurofibrillary tangles that are characteristic of Alzheimer’s disease.

¹⁸F PI-2620 PET can be used to evaluate patients with suspected dementia as tau deposition correlates with neuronal loss and cognitive deficits.

Clinical Trials with approval from Life Molecular Imaging

¹⁸F-Florbetapir

Neurology · Amyloid PET

PET imaging with ¹⁸F Florbetapir can demonstrate deposition of β-amyloid proteins in the brain. β-amyloid accumulates in the brain to form neuritic plaques long before symptoms begin in Alzheimer’s disease. AV-45 PET has clinical utility to demonstrate the presence and density of β-amyloid plaques in the brain in patients with suspected dementia.

TGA Special Access Scheme

Authorised Prescriber

Clinical Trials

¹⁸F-Flortaucipir (¹⁸F-AV-1451)

Neurology · Tau PET

PET imaging with ¹⁸F Flortaucipir can demonstrate deposition of abnormal tau proteins in the brain. Tau has multiple forms and ¹⁸F Flortaucipir binds most avidly to tau 3R+4R in neurofibrillary tangles that are characteristic of Alzheimer’s disease. Tau PET can be used to evaluate patients with suspected dementia as tau deposition correlates with neuronal loss and cognitive deficits.

Clincial trials with pre -approval from AVID Radiopharmaceuticals

¹⁸F-Flutemetamol

Neurology · Amyloid PET

PET imaging with ¹⁸F Flutemetamol can demonstrate deposition of β-amyloid proteins in the brain. β-amyloid accumulates in the brain to form neuritic plaques long before symptoms begin in Alzheimer’s disease. ¹⁸F Flutemetamol PET has clinical utility to demonstrate the presence and density of β-amyloid plaques in the brain in patients with suspected dementia.

TGA Special Access Scheme

Authorised Prescriber

Clinical Trials

How Products Are Supplied

Standard Product Supply

Registered and standard radiopharmaceuticals supplied to hospitals, PET/CT centres and authorised healthcare providers under the appropriate regulatory and commercial arrangements.

TGA Special Access Scheme

Patient-specific access to unapproved radiopharmaceuticals through the Therapeutic Goods Administration (TGA) Special Access Scheme, initiated by the treating clinician.

Authorised Prescriber

TGA Authorised Prescribers may prescribe specific unapproved radiopharmaceuticals for eligible patients without requiring individual Special Access Scheme (SAS) approval.

Clinical Trial/Clinical Trial Notification (CTN) Scheme

Manufacture and supply of investigational radiopharmaceuticals for NHMRC Human Research Ethics Committee (HREC)-approved clinical trials conducted under the Clinical Trial Notification (CTN) scheme, under a contract manufacturing agreement.

This information is general in nature. Access pathways should be confirmed with Cyclotek and the relevant clinical, regulatory or ethics requirements.

Clinical Rebate Programs – Medical benefits Scheme (MBS) – Australia

Australia — MBS (selected indications)

MBS No #	Item Details	Fee ($AUD)	Benefit 75%	Benefit 85%
61523	Whole body FDG PET study, performed for evaluation of a solitary pulmonary nodule where the lesion is considered unsuitable for transthoracic fine needle aspiration biopsy, or for which an attempt at pathological characterisation has failed.(R)	$953	$714.75	$848.5
61529	Whole body FDG PET study, performed for the staging of proven non-small cell lung cancer, where curative surgery or radiotherapy is planned (R)	$953	$714.75	$848.50
61538	FDG PET study of the brain for evaluation of suspected residual or recurrent malignant brain tumour based on anatomical imaging findings, after definitive therapy (or during ongoing chemotherapy) in patients who are considered suitable for further active therapy. (R)	$953	$714.75	$848.50
61541	Whole body FDG PET study, following initial therapy, for the evaluation of suspected residual, metastatic or recurrent colorectal carcinoma in patients considered suitable for active therapy (R)	$752.35	$564.3	$647.85
61553	Whole body FDG PET study, following initial therapy, performed for the evaluation of suspected metastatic or recurrent malignant melanoma in patients considered suitable for active therapy (R)	$1300	$975.00	$1,195.00
61559	FDG PET study of the brain, performed for the evaluation of refractory epilepsy which is being evaluated for surgery (R)	$953	$714.75	$848.50
61565	Whole body FDG PET study, following initial therapy, performed for the evaluation of suspected residual, metastatic or recurrent ovarian carcinoma in patients considered suitable for active therapy. (R)	$901	$675.75	$796.50
61571	Whole body FDG PET study, for the further primary staging of patients with histologically proven carcinoma of the uterine cervix, at FIGO stage IB2 or greater by conventional staging, prior to planned radical radiation therapy or combined modality therapy with curative intent. (R)	$953	$714.75	$848.50
61575	Whole body FDG PET study, for the further staging of patients with confirmed local recurrence of carcinoma of the uterine cervix considered suitable for salvage pelvic chemoradiotherapy or pelvic exenteration with curative intent. (R)	$999	$749.25	$894.50
61577	Whole body FDG PET study, performed for the staging of proven oesophageal or GEJ carcinoma, in patients considered suitable for active therapy (R).	$918	$688.50	$813.50
61598	Whole body FDG PET study performed for the staging of biopsy-proven newly diagnosed or recurrent head and neck cancer (R).	$605.05	$453.80	$514.30
61604	Whole body FDG PET study performed for the evaluation of patients with suspected residual head and neck cancer after definitive treatment, and who are suitable for active therapy (R).	$1300	$975	$1,195.50
61610	Whole body FDG PET study performed for the evaluation of metastatic squamous cell carcinoma of unknown primary site involving cervical nodes (R).	$1300	$975	$1,195.55
61616	Whole body FDG PET study for the initial staging of indolent non-Hodgkin’s lymphoma where clinical, pathological and imaging findings indicate that the stage is I or IIA and the proposed management is definitive radiotherapy with curative intent. (R)	$953	$714.75	$848.50
61620	Whole body FDG PET study for the initial staging of newly diagnosed or previously untreated Hodgkin’s or non-Hodgkin’s lymphoma (excluding indolent non-Hodgkin’s lymphoma. (R)	$953	$714.75	$848.50
61622	Whole body FDG PET study to assess response to first line therapy either during treatment or within three months of completing definitive first line treatment for Hodgkin’s or non-Hodgkin’s lymphoma (excluding indolent non-Hodgkin’s lymphoma), (R)	$953	$714.75	$848.50
61628	Whole body FDG PET study for restaging following confirmation of recurrence of Hodgkin’s or non-Hodgkin’s lymphoma (excluding indolent non-Hodgkin’s lymphoma). (R)	$953	$714.75	$848.50
61632	Whole body FDG PET study to assess response to second-line chemotherapy when stem cell transplantation is being considered, for Hodgkin’s or non-Hodgkin’s lymphoma (excluding indolent non-Hodgkin’s lymphoma). (R)	$953	$714.75	$848.50
61640	Whole body FDG PET study for initial staging of patients with biopsy-proven bone or soft tissue sarcoma (excluding gastrointestinal stromal tumour) considered by conventional staging to be potentially curable. (R)	$953	$714.75	$848.50
61646	Whole body FDG PET study for the evaluation of patients with suspected residual or recurrent sarcoma (excluding gastrointestinal stromal tumour) after the initial course of definitive therapy to determine suitability for subsequent therapy with curative intent.	$953	$714.75	$848.50
61647	Whole body 68Ga DOTA peptide PET study, if: (a) a gastro entero pancreatic neuroendocrine tumour is suspected on the basis of biochemical evidence with negative or equivocal conventional imaging; or (b) both: (i) a surgically amenable gastro entero pancreatic neuroendocrine tumour has been identified on the basis of conventional techniques; and (ii) the study is for excluding additional disease sites (R)	$953	$714.75	$848.50
61530	Whole body 68Ga-DOTA-somatostatin receptor agonist PET study for: a) staging of histologically confirmed neuroendocrine neoplasm (NEN) considered surgically incurable on conventional imaging, or b) evaluation of somatostatin receptor expression of histologically confirmed and inoperable NEN, either locally advanced or metastatic, under consideration for peptide receptor radionuclide therapy (PRRT); or c) evaluation of response to PRRT therapy; or d) evaluation of suspected recurrent or metastatic disease in known somatostatin receptor positive NEN. (R)	$953	$714.75	$848.50

Clinical Rebate Programs – DHB – New Zealand

New Zealand — DHB & Southern Cross (selected indications)

Type	Code	Criteria
Anal	AN1	Staging of patients with locally advanced (>/= T2 +/or node positive) anal squamous cell carcinoma.
Bladder	BL1	Staging of patients with locally advanced or potentially oligometastatic bladder cancer, where other imaging is indeterminate and radical therapy is being considered.
Breast	BR1	Staging of patients with locally advanced or potentially oligometastatic breast carcinoma, where other imaging is indeterminate or non-diagnostic and where radical therapy is being considered (see additional notes in Evidence-based indications for the use of PET-CT in the United Kingdom 2022, Pg13).
Cardiac Sarcoid	CS1	Initial diagnosis or re-evaluation of patients with sarcoidosis with suspected cardiac involvement, where cardiac MRI is indeterminate or not feasible due to ICD
Colorectal	CR1	Pre-operative evaluation of patients with colorectal carcinoma who are candidates for resection of metastases.
	CR2	Re-staging of patients with colorectal carcinoma and new abnormality on other imaging following definitive treatment
	CR3	Re-staging of patients with rising tumour markers with indeterminate findings on other imaging following definitive treatment for colorectal carcinoma.
	CR4	Re-staging of patients with loco-regionally recurrent colorectal cancer where pelvic exenteration is being considered
Epilepsy	EP1	Evaluation for focal hypometabolism in refractory partial epilepsy.
Germ cell	GE1	Staging of patients with germ cell tumour where curative therapy is being considered.
GIST	GI1	Restaging of patients with recurrent gastrointestinal stromal tumour (GIST) where curative resection is being considered.
Glioma	GL1	FET PET scan to guide biopsy or target delineation for radiotherapy planning in patients with heterogeneous tumours on MR scan
	GL2	FET PET scan for differentiation of radio necrosis from recurrent glioma in patients treated with radiotherapy
Graft Infection	GR1	Evaluation of patients with suspected vascular graft, cardiac prosthesis or pacemaker infection where other imaging is indeterminate
Cervical	GY1	Staging of patients with locally advanced (>FIGO Stage 1A) cervical (includes vaginal and vulval) cancer where curative therapy is being considered
	GY2	Staging of patients with histologically proven, loco-regionally recurrent cervical, vaginal or uterine cancer, where radical therapy is being considered.
	GY4	Restaging of patients with locally advanced cervical, vaginal or vulval cancer 3-6 months post radical treatment with chemoradiotherapy.
Hepatobiliary	HB2	Staging of patients with gallbladder or bile duct cancer which appears localised on other imaging and where radical surgery is being considered
Head and Neck	HN0	Staging of locally advanced/node positive head and neck cancer
	HN1	Restaging of head and neck cancers following definitive treatment or for a residual/recurrent mass.
	HN3	Staging of patients with metastatic SCC in head and neck lymph nodes from an unknown primary with indeterminate findings on other imaging and where radical therapy is being considered
Lung	LU1	Staging of patients with suspected or proven lung cancer (SCLC or NSCLC) where radical treatment is being considered.
	LU2	Evaluation of a pulmonary nodule, minimum diameter of at least 8 mm, where the risk of malignancy is moderate or high, in line with international guidance (reference BTS and Fleischner)
Lymphoma	LYM1	Staging of patients with Hodgkin’s Disease and restaging after 2-4 cycles of chemotherapy to inform management options
	LYM2	Staging of patients with early stage Non Hodgkin’s lymphoma to guide indication for radiation and appropriate treatment fields
	LYM3	Initial staging and restaging at the end of treatment PET CT for High Grade Non-Hodgkin’s Lymphoma
	LYM4	Restaging of patients with residual mass in Hodgkin’s and Non Hodgkin’s lymphoma following definitive treatment
	LYM5	Evaluation of response to salvage chemotherapy in patients who are candidates for stem cell transplantation
	LYM6	Suspected transformation to high grade lymphoma in patients with either SLL/CLL or low grade NHL to guide biopsy site
	LYM7	Restaging of patients with low grade lymphoma at the end of treatment to guide indication for maintenance Rituximab therapy
Myeloma	MY1	Staging of patients with non-secretory, oligosecretory or extramedullary myeloma, or solitary plasmocytoma, where other imaging is non-diagnostic or indeterminate
Neuroendocrine	NE1	68Ga-DOTATATE for perioperative staging of patients with neuroendocrine tumour.
	NE2	68Ga-DOTATATE and/or 18F-FDG PET for assessment of patients with neuroendocrine tumours for suitability for PRRT or response to PRRT
Oesophagus	OE1	Staging of patients with oesophageal and gastro-oesophageal junction cancer where radical treatment is being considered.
	OE2	Restaging of patients with oesophageal and gastro-oesophageal junction cancer with suspected recurrence where radical treatment is being considered
Ovarian	OV1	Restaging of patients with recurrent ovarian and fallopian tube carcinoma where cytoreductive/ curative surgery is being considered
Pancreas	PANC1	Staging of patients with pancreatic cancer where radical surgery is being considered
Prostate	PROS1	PSMA PET-CT to be used for initial staging of patients with high-risk prostate cancer (PSA>20, Gleason ≥8, T3a) that are otherwise suitable for locoregional therapy with curative intent.
	PROS2	PSMA PET-CT to be used for restaging of patients with biochemical recurrence (PSA>0.5 post-prostatectomy or 2 above nadir post radical radiotherapy) that are otherwise suitable for further locoregional therapy. Any single patient will only have a maximum of two restaging PSMA PET-CTs per lifetime
Pyrexia of unknown origin	PU1	Investigation of sustained pyrexia despite antibiotics for ›3 weeks where all other investigations have been exhausted and the scan is recommended by an infectious diseases or general medicine consultant
Sarcoma	SA1	Staging of patients with localised, intermediate or high grade sarcoma, where radical therapy is being considered.
	SA2	Re-staging of residual masses in patients with Ewing’s sarcoma or rhabdomyosarcoma
Skin	SK1	Staging or restaging of locally advanced or metastatic melanoma for patients who are suitable for treatment with curative intent
	SK2	Staging prior to radical therapy for patients with biopsy proven Merkel cell carcinoma.
	SK3	Staging or restaging of locally advanced cutaneous Squamous cell carcinoma for patients who are otherwise suitable for locoregional therapy with curative intent
Testicular cancer	TE1	Restaging of residual masses in patients with testicular cancer post-definitive treatment
Thyroid	TH1	Assessment of patients with suspected, recurrent thyroid carcinoma based on elevated thyroglobulin where other imaging is negative or indeterminate

PET Radiopharmaceuticals