Cyclotek extemporaneously compounds PET Radiopharmaceuticals made to order by customers for particular persons

18F Fludeoxyglucose (FDG)

This radiopharmaceutical is 2-deoxy-2-fluoro-D-glucose radiolabeled with 18F. 18F-FDG is a high affinity substrate for glucose transporter type 1 (GLUT1) that is strongly overexpressed in many types of lethal cancer that characteristically use increased amounts of glucose. After uptake 18F-FDG is bound with the cell allowing visualisation of abnormal cancer cell glucose metabolism throughout the body when combined with positron emitting tomography (PET) imaging. Cancers that are invisible to all other forms of imaging are often detected using 18F-FDG PET imaging has led to widespread use of this technique for guiding treatment in many different cancer indications and some government assistance is provided through the Medical Benefits Scheme.


18F DCFPyL (PSMA – PSR)

This radiopharmaceutical is a urea-based molecule radiolabeled with 18F.  18F-DCFPyL binds to the enzymatic site of prostate specific membrane antigen (PSMA) inhibiting PSMA activity and is strongly internalised. Very often PSMA is  strongly overexpressed in prostate cancer cells, particularly more aggressive forms including metastatic and androgen resistant tumours, but is present in much lower amounts in most normal tissues. When combined with positron emitting tomography (PET) imaging 18F-DCFPyL,provides highly specific and sensitive visualisation of sites of prostate cancer throughout the body. A large body of evidence indicates that PSMA PET imaging, including with 18F-DCFPyL, provides unique information for guiding treatment decisions in men with prostate cancer, particularly in the setting of primary staging of intermediate and high risk prostate cancer and Biochemical Recurrence.

Cyclotek is undertaking and supporting further clinical trials with the use of 18F-DCFPyL.


18F 16 alpha-fluoroestradiol (FES)

This radiopharmaceutical is an estradiol analogue radiolabeled with 18F. In normal women estradiol is a major form of estrogen that acts via estrogen receptors (ER) to regulate a range of normal cellular functions in the breast and reproductive tissues. A large percentage of breast cancers overexpress ER and diminishing the stimulatory effects of estrogen is a common form or breast cancer treatment. 18F-FES maintains a high affinity for ER and so facilitates high specificity visualization of ER-positive tissues and particularly tumours throughout the body when combined with positron emitting tomography (PET )imaging.

Cyclotek is working with and supporting clinical investigators to better define the clinical role of 18F-FES in the management of breast cancer patients.


18F fluoroethyltyrosine (FET)

This radiopharmaceutical is the amino acid analog ethyl tyrosine radiolabeled with 18F Fluorine. 18F-FET is a substrate for the Large Amino Acid Transporter 1 (LAT1) that is overexpressed in many tumour cells. 18F-FET is actively transported into cells according to their LAT1 concentration but neither incorporated into proteins nor readily degraded and therefore able to be transported out the cell again. 18F-FET can be transported across the blood brain barrier and has been shown to have high retention in gliomas across the spectrum of tumour grades relative to normal brain uptake. Research has shown that 18F-FET combined with positron emitting tomography (PET )imaging can provide unique diagnostic information and treatment guidance for a range of clinical indications involving glioma management.

18F-FDG is also actively concentrated by brain tumours at levels that correlate with the grade of the glioma, however the high uptake of 18F-FDG in normal brain limits the use of this radiopharmaceutical for assessing gliomas.

Cyclotek is working with and supporting clinical investigators to better define the clinical role of 18F-FET in glioma patient management.


18F sodium fluoride (NaF)

This radiopharmaceutical is the sodium salt of 18F Fluoride that allows investigation of bone mineralisation with positron emitting tomography (PET ) imaging.  Almost all Na18F delivered in the blood is extracted by bone in a single pass so this tracer is a reliable indicator of relative regional bone blood flow. Na18F passes from the blood to the bone extracellular fluid and into the shell of bound water surrounding each hydroxyapatite crystal. Chemisorption follows whereby 18F exchanges with OH on the surface of the hydroxyapatite crystal to form fluorapatite. Na18F uptake and retention in bone depends on the area of “exposed” bone surface which is larger in a variety of benign and malignant bone disorders giving rise to regions of high Na18F uptake or “hot spots”.

Na18F PET bone scans provide similar information to conventional bone scans with greater spatial and contrast resolution and with a much shorter delay between administration of the radiopharmaceutical and scanning leading to a shorter overall procedure time.

PET images may include the whole skeleton or only symptomatic regions.

This product is available only in New Zealand.

Neurology

18F Florbetaben

Florbetaben, an 18F-labeled stilbene derivative, trade name NeuraCeq™ (Florbetaben F18 injection for Australia and New Zealand), is a diagnostic radiopharmaceutical developed to visualize ß-amyloid plaques in the brain. The tracer successfully completed a global multicenter phase 0–III development program. Neuraceq was first approved in the EEA via a centralized procedure on 20 Feb 2014. It was subsequently approved in the United States on 19 Mar 2014, and has also been approved in South Korea, Japan , Canada, Switzerland, Taiwan.

Accurate diagnosis and early identification of cognitive and functional impairment due to AD and other etiologies are critical for optimization of patient care and initiation of appropriate therapies. Life Molecular Imaging’s focus on AD is driven by the limitations of conventional diagnostic modalities. Although history-taking, neuropsychological tests and structural brain imaging are considered a mainstay of clinical diagnosis in patients with evidence of cognitive decline, these tests cannot diagnose AD with very high certainty particularly at an early stage, nor can they sufficiently rule out AD as the underlying etiology of cognitive decline.

Better detection methods of the neuropathological hallmarks of AD are therefore needed to reduce the frequency of misdiagnosis. Fortunately, radiotracers applied with modern imaging technologies are now available to accurately detect these protein depositions. When used in conjunction with other clinical tests, in vivo imaging technologies and molecular imaging in particular can assist in the diagnosis of AD by detecting the presence or absence of ß-amyloid plaques.

Beta-amyloid imaging has been incorporated into major AD therapeutic trials. There are several compounds currently investigated that have shown beta-amyloid reduction after treatment using beta-amyloid PET imaging. For a comprehensive overview, please see the following article (https://www.alzforum.org/news/conference-coverage/four-immunotherapies-now-banish-amyloid-brain). The effect on cognition of removing  beta-amyloid from the brain is to be determined. Cyclotek is working with and supporting pharmaceutical & clinical investigators to understand the utilisation for FBB. Cyclotek have validated the manufacture of 18F FBB for clinical trials and under the Special Access Scheme for use in Australia and New Zealand.

Please contact Mr Greg Santamaria, enquiries@cyclotek.com.

Please see further information at https://life-mi.com/


18F PI-2620

LMI have a 18F-labeled compound targeting Tau, a potential biomarker for diagnosing non-AD dementias as well as for monitoring neurodegeneration in AD-related dementia. Tau tangles are an important measure of neuronal death and correlate strongly with cognitive decline. Detection of Tau may therefore contribute to advanced monitoring of cognitive performance in patients with dementia. With PI-2620 a suitable lead compound has been identified, that is currently being further investigated in clinical studies. Cyclotek have validated the manufacture of PI-2620 for clinical trial use in Australia and New Zealand.

Please contact Mr Greg Santamaria, enquiries@cyclotek.com.

Please see further information at https://life-mi.com/

Selected recent publications about PI-2620

  • Mueller et al. (2019) Tau PET imaging with 18F-PI-2620 in patients with Alzheimer’s disease and healthy controls: a first-in-human study. JNM – 10.2967/jnumed.119.236224 
  • Bullich et al. (2019) Evaluation of dosimetry, quantitative methods and test-retest variability of 18F-PI-2620 PET for the assessment of tau deposits in the human brain. JNM –  doi:10.2967/jnumed.119.236240
  • Kroth et al. (2019) Discovery and preclinical characterization of [18F]PI-2620, a next-generation tau PET tracer for the assessment of tau pathology in Alzheimer’s disease and other tauopathies. EJNMMI – PDF file open-access: click here

18F FEMPA

Imaging of the 18-kDa translocator protein (TSPO) is a potential tool for examining microglial activation and neuroinflammation in early Alzheimer’s disease (AD). [(18)F]FEMPA is a novel high-affinity second-generation TSPO radioligand that has displayed suitable pharmacokinetic properties in preclinical studies.

Please contact Mr Greg Santamaria, enquiries@cyclotek.com.

Listing of publications and/or trials

PET Immunotherapies

Under Construction.

FDG – Clinical Rebates Australia

MBS No# Item Detail
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)
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)
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)
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)
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)
61559 FDG PET study of the brain, performed for the evaluation of refractory epilepsy which is being evaluated for surgery (R)
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)
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)
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)
61577 Whole body FDG PET study, performed for the staging of proven oesophageal or GEJ carcinoma, in patients considered suitable for active therapy (R).
61598 Whole body FDG PET study performed for the staging of biopsy-proven newly diagnosed or recurrent head and neck cancer (R).
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).
61610 Whole body FDG PET study performed for the evaluation of metastatic squamous cell carcinoma of unknown primary site involving cervical nodes (R).
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)
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)
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)
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)
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)
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)
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. (R)

FDG – Clinical Rebates – New Zealand DHB’s

Indication Item Detail
Colorectal 1. Preoperative evaluation for patients considered for resection of hepatic/lung metastases in colorectal carcinoma (CRC)2. Evaluation of residual structural abnormality on diagnostic imaging following definitive treatments for colorectal carcinoma (CRC)
Lung 3. Staging of proven non-small cell lung cancer (NSLC) prior to curative surgery or radiotherapy4. Solitary pulmonary nodules not amenable to fine needle aspiration (FNA) or which have failed pathological characterisation
Lymphoma 5. Restaging of residual mass for Non-Hodgkin’s Lymphoma following definitive treatment6. Staging of early stage low-grade Non-Hodgkin’s Lymphoma7. Staging of Hodgkin’s Disease
Head and Neck 8. Restaging of residual neck masses in head and neck cancers following radiotherapy/chemotherapy9. Staging for metastatic squamous carcinoma in cervical lymph nodes fromunknown primary
Oesophagus 10. Staging of gastric/oesophageal cancer for curative treatment
Malignant Melanoma 11. Patients considered for definitive or adjuvant treatment of oligo-metastatic or regional melanoma
Cervical 12. Staging of locally advanced cervical cancer for curative radiation treatment
Ovarian 13. Restaging of recurrent ovarian carcinoma being considered for cytoreductive surgery
Other The condition is outside the above criteria and will need to be approved by the PET Variance Committee.

FDG – Clinical Rebates New Zealand

Cancer Clinical Indication
1. Non Small Cell Lung Cancer (NSCLC) For staging of NSCLC prior to radiotherapy or surgery with curative intent- For the evaluation of isolated pulmonary nodules not amenable to FNA or which have failed pathological characterisation
2. Small Cell Lung Cancer (SCLC) For staging of patients with clinical stage T1-2 M0 after standard staging evaluation where chemotherapy and radiotherapy is being considered
3. Colorectal Cancer (CRC) Preoperative evaluation of patients being considered for resection of hepatic/lung metastases- Restaging of CRC in patients who are symptomatic or have signs of suspected metastatic or recurrent disease following definitive treatment
4. Lymphoma Staging of newly diagnosed Lymphoma- Restaging of residual mass after definitive treatment of Lymphoma
5. Head and Neck Cancer Staging of newly diagnosed head and neck cancers with suspected metastatic disease- Restaging of residual neck masses in head and neck cancers following definitive therapy
6. Oesophageal Cancer Staging of locally advanced oesophageal cancer or gastro-oesophageal junction cancer
7. Malignant Melanoma Evaluation of local and regional disease spread in patients with high risk melanoma being considered for definitive surgical resection (AJCC Stages III and IV)- Restaging of Metastatic Melanoma which is being considered for active therapy
8. Cervical Cancer Staging of advanced cervical cancer prior to surgery, chemotherapy and radiotherapy
9. Ovarian Cancer Restaging of ovarian cancer with suspected residual, metastatic or recurrent disease in patients being considered for definitive therapy
10. Thyroid Cancer Restaging of recurrent disease following initial definitive therapy
11. Evaluation of Cancer of Unknown Primary Evaluation of metastatic lymph nodes from cancer of unknown primary
12. Testicular Cancer Evaluation of post treatment residual mass in patients with advanced germ cell tumours
13. Breast Cancer Staging of cases with distant metastases or restaging cases of loco-regional recurrence- Staging of advanced breast tumours (T3, N1 +) or T4 tumours for metastatic disease
14. Gastrointestinal Stromal Tumours (GIST) Staging and restaging of GIST
We will also reimburse for the Services under this Agreement for cancers outside of the above criteria where the Services are considered medically necessary to evaluate or stage the particular condition, provided that You document your reason why the Services are medically necessary and obtain a second specialist’s endorsement to support Your view.This specialist endorsement must come from a different specialty to Yours and be either from a surgeon, medical oncologist or radiation oncologist.In addition:- The PET/CT scan must be referred by a medical practitioner Band III or Band IV in private practice following a clinical consultation; and- The condition requiring the Services must not be acuteAnd finally the terms and conditions of the Member’s policy must be met at the time of Services are provided (as determined by Us).

Other Products – Clinical Rebates New Zealand

Cancer Clinical Indication
15. Brain Cancer
(Using 18F-FET)
Differentiation between high and low grade gliomas- For the differentiation of recurrent
tumours from radiation necrosis
16. Breast Cancer
(Using 18F-NaF)
Initial staging in high risk breast cancer (Clinical Stage IIIA or higher) or :- Initial staging
in clinical stage I-IIB breast cancer with symptoms of bone pain or elevated alkaline
phosphatase levels suggesting the presence of bone metastases- Restaging of all
stage disease with symptoms of bone pain or elevated alkaline phosphatase levels
strongly suggestive of the presence of bone metastases
17. Prostate Cancer
(Using 18F-NaF)
Staging or high risk prostate cancer defined as:* Stage T1 and PSA > 20 or* Stage T2 and PSA > 10 or* Gleason Score ≥ 8 or T3, T4 disease or
* Any disease stage with symptoms strongly suggestive of bone metastases