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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01207895
Recruitment Status : Completed
First Posted : September 23, 2010
Last Update Posted : February 23, 2017
Information provided by (Responsible Party):
Henry C. Manning, PhD, Vanderbilt-Ingram Cancer Center

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Device: PET imaging with [18F]-FLT Drug: [18F]-fluorodeoxythymidine Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
Study Start Date : March 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Telbivudine

Arm Intervention/treatment
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.

Drug: [18F]-fluorodeoxythymidine
[18F]-fluorodeoxythymidine is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Correlative biology [ Time Frame: 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

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
First Posted: September 23, 2010    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Antiviral Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action