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

This study has been completed.
Information provided by (Responsible Party):
Henry C. Manning, PhD, Vanderbilt-Ingram Cancer Center Identifier:
First received: September 17, 2010
Last updated: May 9, 2016
Last verified: May 2016
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.

Condition Intervention
Rectal Cancer
Device: PET imaging with [18F]-FLT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer

Resource links provided by NLM:

Further study details as provided by Vanderbilt-Ingram Cancer Center:

Primary Outcome Measures:
  • Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer [ Time Frame: at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery ] [ Designated as safety issue: No ]
    Ability of this imaging technique to determine growth of cancer cells and as a quantitative biomarker of response to relevant, molecularly targeted, therapies

Secondary Outcome Measures:
  • Correlative biology [ Time Frame: at study entry before treatment, at week 3 of treatment, and at week 11 after treatment ] [ Designated as safety issue: No ]
    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

Enrollment: 5
Study Start Date: March 2010
Study Completion Date: July 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [18F]-FLT PET scans Device: PET 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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts 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
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Please refer to this study by its identifier: NCT01207895

United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Principal Investigator: Henry Manning, Ph.D. Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Responsible Party: Henry C. Manning, PhD, Assistant Professor of Radiology, Neurosurgery, Biomedical Engineering, Program in Chemical and Physical Biology, Vanderbilt-Ingram Cancer Center Identifier: NCT01207895     History of Changes
Other Study ID Numbers: VICC GI 0993 
Study First Received: September 17, 2010
Last Updated: May 9, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms by Site
Rectal Diseases processed this record on May 26, 2016