Back to resultsMolecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
Primary Purpose
Rectal Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PET imaging with [18F]-FLT
[18F]-fluorodeoxythymidine
Sponsored by
About this trial
This is an interventional basic science trial for Rectal Cancer
Eligibility 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
Sites / Locations
- Vanderbilt-Ingram Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F]-FLT PET scans
Arm Description
Outcomes
Primary Outcome Measures
Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer
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
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
Full Information
NCT ID
NCT01207895
First Posted
September 17, 2010
Last Updated
February 18, 2017
Sponsor
Vanderbilt-Ingram Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01207895
Brief Title
Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
Official Title
Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
July 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
[18F]-FLT PET scans
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PET imaging with [18F]-FLT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
[18F]-fluorodeoxythymidine
Intervention Description
[18F]-fluorodeoxythymidine is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
Primary Outcome Measure Information:
Title
Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer
Description
Ability of this imaging technique to determine growth of cancer cells and as a quantitative biomarker of response to relevant, molecularly targeted, therapies
Time Frame
at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery
Secondary Outcome Measure Information:
Title
Correlative biology
Description
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
Time Frame
at study entry before treatment, at week 3 of treatment, and at week 11 after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Manning, Ph.D.
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.vicc.org/ct/
Description
Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Learn more about this trial
Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
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