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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henry C. Manning, PhD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01207895
First received: September 17, 2010
Last updated: January 17, 2014
Last verified: January 2014
  Purpose

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: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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: December 2013
Primary Completion Date: December 2013 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01207895

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

Additional Information:
No publications provided

Responsible Party: Henry C. Manning, PhD, Assistant Professor of Radiology, Neurosurgery, Biomedical Engineering, Program in Chemical and Physical Biology, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT01207895     History of Changes
Other Study ID Numbers: VICC GI 0993
Study First Received: September 17, 2010
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 30, 2014