A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma

Study Overview
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Brief Summary
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The Radiotracer 18F-FLT can non-invasively assess excessive cell growth in PET scan images. Tumour growth rate is a useful indicator of tumour aggression and response to treatment. Imaging and measuring the cell growth with 18F-FLT may be useful in monitoring response to anticancer treatment.

Detailed Description
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Clinical trial is a combined Phase I/II imaging, open label, single site study in patients with known or suspected carcinoma of the lung, breast, renal cell, pancreas or brain, and with gastrointestinal malignancies, neuroendocrine tumours, or lymphoma. One 18F-FLT PET scan will be performed in 10 Phase I patients, and pre-injection and post-imaging blood work and vital signs will be collected. Up to 5 18F-FLT PET scans will be performed in 170 Phase II patients.

Official Title
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A Contiguous, Sequential Phase I/II Imaging Study of 18F-fluoro-3'-L-fluorothymidine (18F-FLT) in Patients With Known or Suspected Carcinoma of the Lung, Breast, Renal Cell, Pancreas, or Brain, and With Gastrointestinal Malignancies, Neuroendocrine Tumours or Lymphoma

Conditions
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Brain Cancer, Cancer, Solid Tumor, Lymphoma

Intervention / Treatment
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* Biological: 18F-FLT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female greater than or equal to 16 years of age. If female of child-bearing potential and outside of the window of 10 days since the first day of last menstrual period, a negative pregnancy test is required. Patients with known primary or suspected primary, recurrent or metastatic carcinoma of the lung, breast, renal cell, pancreas or brain (including GGM, oligodendrogliomas, and brain metastases from any primary tumour) and with gastrointestinal malignancies, neuroendocrine tumours (including carcinoid and islet cell malignancies, or lymphoma, with at least one lesion >1 cm in diameter. Biochemical parameters as measured are required to be within 5 times the normal limits for age. Able and willing to follow instruction and comply with the protocol Provide written informed consent prior to participation in the study Karnofsky Performance Scale Score 50-100 Exclusion Criteria: Previous removal of entire tumour Biochemical parameters as measured outside 5 times the normal limits for age Unable or unwilling to follow instructions and comply with the protocol Unable or unwilling to provide written informed consent prior to participation in the study Karnofsky Performance Scale Score < 50 Nursing or pregnant females Age less than 16 years

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>18F-FLT PET | Biological: 18F-FLT<br>* Phase I: Radioactive dose of 2.59 MBq/kg (111-222 MGq)per injection. A single injection of 18F-FLT and PET scan will be permitted per patient. Phase II: Radioactive dose of 2.59 MBq/kg (100-350) MBq per injection. Up to five separate injections of 18F-FLT and PET scans will be permitted per patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: to determine the safety of 18 F-FLT. |  | 3 years | 
| Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phase I: To determine general biodistribution of 19F-FLT |  | 3 years | 
| Phase II: to confirm safety of 18F-FLT; to determine the relative uptake of 18F-FLT (SUV, RUS, T/N); and to correlate 18F-FLT uptake with patient outcomes. |  | 3 years | 
| Phase II: to correlate 18F-FLT uptake with patient outcomes (treatment response, progression-free survival, overall survival), over the first 12 months of follow-up after completion of tx, subsequently over the remainder of the disease course |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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18F-FLT, Positive Emission Tomography, Cancer