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Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer


N/A
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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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 CenterNashville, Tennessee  37232-6838