Using Positron Emission Tomography to Evaluate the Effects of Bevacizumab on Intra-tumoral Pharmacokinetics of 5-fluorouracil in Metastatic Colorectal Cancer
- This is not a treatment study. A treatment regimen has already been decided upon by
the patient and doctor.
- At the screening visit for this trial the following will be performed: a medical
history, physical examination, CT scan to measure the amount and size of the tumor(s),
and a PET scan using glucose that has been attached to a small amount of radioactivity
to determine how well the tumor takes up glucose.
- Patients will then be randomized into one of 2 treatment groups. Group 1 will receive
both 5-FU and bevacizumab on the first day of chemotherapy. Group 2 will receive just
5-FU on the first day of chemotherapy.
- Patients will undergo a PET scan that uses water that has been attached to a small
amount of radioactivity to measure how well the tumor takes up water prior to the 5-FU
- After patients receive 5-Fu they will undergo a PET scan during which a small amount of
5-FU has been attached to a small amount of radioactivity to measure how well the tumor
takes up 5-FU.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To compare the percent change in tumor radioactivity uptake and retention after radiolabeled fluorouracil administration in subjects who receive bevacizumab versus those who do not receive bevacizumab.
David Ryan, MD
Massachusetts General Hospital
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|