Rectal Cancer
Conditions
Brief summary
The purpose of this study is to determine if positron emission tomography (PET) imaging with an imaging agent called 18F-fluorodeoxythymidine(\[18F\]-FLT) will allow investigators to measure how well tumor(s) respond to treatment without taking a tissue sample (biopsy). Additionally, the investigators want to determine if it is possible to predict how well tumor(s) might respond to treatment with \[18F\]-FLT PET imaging.
Interventions
DEVICEPET imaging with [18F]-FLT
Up to three \[18F\]-FLT PET scans; one before beginning treatment, one at week three of treatment, and one at week 11, after completion of treatment but prior to surgery.
DRUG[18F]-fluorodeoxythymidine
\[18F\]-fluorodeoxythymidine is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Sponsors
Vanderbilt-Ingram Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with known rectal cancer. * Subjects must have signed an approved consent form. * Subjects must be 18 years of age or older.
Exclusion criteria
* Children less than 18 are excluded. * Pregnant women and women who are breast feeding will be excluded from this study. A serum beta HCG will also be performed for each pre-menopausal female subject. * Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer | at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery | Ability of this imaging technique to determine growth of cancer cells and as a quantitative biomarker of response to relevant, molecularly targeted, therapies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlative biology | at study entry before treatment, at week 3 of treatment, and at week 11 after treatment | Pre-treatment and intra-treatment rectal biopsy tissue and tissue from the post-treatment surgical tumor resection will be examined for cyclin D1, TK1, PCNA, pHis-H3, thymidylate, p-Erk, p-Akt to identify changes from pre-treatment to post-treatment |
Countries
United States
Outcome results
None listed