A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma
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ClinicalTrials.gov Identifier: NCT01065805 |
Recruitment Status :
Terminated
(Retirement of former Qualified Investigator and lack of resources to complete study)
First Posted : February 9, 2010
Last Update Posted : August 22, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Brain Cancer Cancer Solid Tumor Lymphoma | Biological: 18F-FLT | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 94 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | 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 |
Actual Study Start Date : | March 20, 2009 |
Actual Primary Completion Date : | February 25, 2019 |
Actual Study Completion Date : | February 25, 2019 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
18F-FLT PET
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Biological: 18F-FLT
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 |
- Phase I: to determine the safety of 18 F-FLT. [ Time Frame: 3 years ]
- Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores. [ Time Frame: 3 years ]
- Phase I: To determine general biodistribution of 19F-FLT [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 3 years ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01065805
Canada, Alberta | |
Cross Cancer Institute | |
Edmonton, Alberta, Canada, T6G 1Z2 |
Principal Investigator: | Michael B Sawyer, MD | Cross Cancer Institute |
Responsible Party: | AHS Cancer Control Alberta |
ClinicalTrials.gov Identifier: | NCT01065805 |
Other Study ID Numbers: |
DX-FLT-002 |
First Posted: | February 9, 2010 Key Record Dates |
Last Update Posted: | August 22, 2019 |
Last Verified: | February 2019 |
18F-FLT Positive Emission Tomography Cancer |
Lymphoma Brain Neoplasms Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Central Nervous System Neoplasms |
Nervous System Neoplasms Neoplasms by Site Brain Diseases Central Nervous System Diseases Nervous System Diseases Alovudine Antiviral Agents Anti-Infective Agents |