Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
18 Years
N/A
Both
Rectal Cancer
Trial Information
Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer
Outcome Description:
Ability of this imaging technique to determine growth of cancer cells and as a quantitative biomarker of response to relevant, molecularly targeted, therapies
Outcome Time Frame:
at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery
Safety Issue:
No
Principal Investigator
Henry Manning, Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
VICC GI 0993
NCT ID:
NCT01207895
Start Date:
March 2010
Completion Date:
December 2016
Related Keywords:
- Rectal Cancer
- Rectal Neoplasms
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
