Back to resultsA Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma
Primary Purpose
Brain Cancer, Cancer, Solid Tumor
Status
Terminated
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
18F-FLT
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Cancer focused on measuring 18F-FLT, Positive Emission Tomography, Cancer
Eligibility Criteria
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
Sites / Locations
- Cross Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
18F-FLT PET
Outcomes
Primary Outcome Measures
Phase I: to determine the safety of 18 F-FLT.
Phase II: To determine general biodistribution of 18F-FLT and correlate 18F-FLT uptake with hENT1 expression and Ki-67 scores.
Secondary Outcome Measures
Phase I: To determine general biodistribution of 19F-FLT
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.
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
Full Information
NCT ID
NCT01065805
First Posted
December 19, 2008
Last Updated
August 21, 2019
Sponsor
AHS Cancer Control Alberta
1. Study Identification
Unique Protocol Identification Number
NCT01065805
Brief Title
A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
Retirement of former Qualified Investigator and lack of resources to complete study
Study Start Date
March 20, 2009 (Actual)
Primary Completion Date
February 25, 2019 (Actual)
Study Completion Date
February 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Cancer, Cancer, Solid Tumor, Lymphoma
Keywords
18F-FLT, Positive Emission Tomography, Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
18F-FLT PET
Intervention Type
Biological
Intervention Name(s)
18F-FLT
Intervention Description
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
Primary Outcome Measure Information:
Title
Phase I: to determine the safety of 18 F-FLT.
Time Frame
3 years
Title
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
Secondary Outcome Measure Information:
Title
Phase I: To determine general biodistribution of 19F-FLT
Time Frame
3 years
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Sawyer, MD
Organizational Affiliation
Cross Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Study to Demonstrate the Safety and Preliminary Efficacy of 18F-FLT in Patients With Solid Tumours or Lymphoma
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