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

Fludeoxyglucose (FDG)

18F-FDG or FDG, is a radiopharmaceutical used in positron emission tomography (PET). Chemically, it is 2-deoxy-2-(18F)fluoro-D-glucose, a glucose analog, with the positron-emitting radioactive isotope fluorine-18 substituted for the normal hydroxyl group at the 2′ position in the glucose molecule. The uptake of 18F-FDG by tissues is a marker for the tissue uptake of glucose, which in turn is closely correlated with certain types of tissue metabolism.

Cancer cells usually exhibit an exceptional hunger for glucose, so tumours show up as “hot spots” of FDG concentration relative to most normal tissues.

PET can reveal cancer that is invisible to all other forms of imaging leading to better treatment choices, better assessment of treatment response and earlier detection of recurrence.


18F DCFPyL (PSMA – PSR)

A urea-based radiotracer composed of the prostate specific membrane antigen (PSMA)-targeting agent DCFPyL and labeled with the positron-emitting isotope, fluorine F 18, that can potentially be used for positron emitting tomography (PET) imaging. Upon administration of 18F DCFPyL, the DCFPyL moiety binds to PSMA expressed on tumor cells. The fluorine F 18 moiety facilitates PET imaging of PSMA-expressing tumor cells. PSMA, a cell-surface antigen, is abundantly present on the surface of prostate cancer cells. Investigators Brochure available upon request. Cyclotek is undertaking and supporting further clinical trials with the use of 18F DCFPyL.


18F 16 alpha-fluoroestradiol (FES)

A radiopharmaceutical consisting of an estradiol analogue radiolabeled with the positron-emitting isotope fluorine 18F. FES is actively taken up in tumor cells expressing the estrogen receptor (ER), allowing visualization of ER-positive tumor cells with positron emiision tomography (PET). Uptake of this agent depends upon the ER status of target tissues. Cyclotek is working with and supporting clinical investigators to understand the utilisation for FES


18F fluoroethyltyrosine (FET)

An amino acid analog radiolabeled with fluorine 18F reflecting the increased amino acid transport capacity of tumor cells. FET is actively taken up in tumor cells via amino acid transport system L, but is neither incorporated into proteins nor readily degraded, resulting in high intracellular concentrations of this imaging agent. Radiolableled amino acid-based agents are useful in PET brain tumor imaging because FDG, commonly used in PET tumor imaging, is relatively insensitive for detecting tumors in the brain due the high levels of glycolytic metabolism in the normal cortex and to a lesser extent in white matter.


fluorine 18F sodium fluoride (NaF)

A radiopharmaceutical consisting of the sodium salt of fluorine 18F fluoride with radioisotopic and bone mineralizing activities. Fluoride binds to calcium ions in hydroxyapatite crystals in bone. The uptake and incorporation of positron-emitting fluorine 18F fluoride into bone can be imaged using positron emission tomography (PET) allowing visualization of malignant bone lesions in which regional blood flow and bone turnover are increased.

Neurology

Under Construction

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