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

February 18, 2017 updated by: Henry C. Manning, PhD, Vanderbilt-Ingram Cancer Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt-Ingram Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at study entry before treatment, at week 3 of treatment, and at week 11 after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Investigators

  • Principal Investigator: Henry Manning, Ph.D., Vanderbilt-Ingram Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

September 17, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 23, 2010

Study Record Updates

Last Update Posted (Actual)

February 23, 2017

Last Update Submitted That Met QC Criteria

February 18, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC GI 0993

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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