A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma
Verified June 2014 by AHS Cancer Control Alberta
Information provided by (Responsible Party):
AHS Cancer Control Alberta
First received: December 19, 2008
Last updated: June 10, 2014
Last verified: June 2014
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.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||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
Primary Outcome Measures:
- Phase I: to determine the safety of 18 F-FLT. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Phase I: To determine general biodistribution of 19F-FLT [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2015 (Final data collection date for primary outcome measure)
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
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.
|Ages Eligible for Study:
||16 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065805
|Cross Cancer Institute
|Edmonton, Alberta, Canada, T6G 1Z2 |
|Principal Investigator: Alexander J. B. McEwan, MD |
|Sub-Investigator: M ichael B Sawyer, MD |
|Sub-Investigator: Andrew R Belch, MD |
|Sub-Investigator: John Mercer, BSc, MSc, PhD |
|Sub-Investigator: Emmanuel Hudson, BMedSc, MD |
AHS Cancer Control Alberta
||Alexander J. B. McEwan, MB, BS, MSc
||Cross Cancer Institute
||AHS Cancer Control Alberta
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 19, 2008
||June 10, 2014
||Canada: Health Canada
Keywords provided by AHS Cancer Control Alberta:
Positive Emission Tomography
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 04, 2016
Immune System Diseases
Neoplasms by Histologic Type