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

Phase 1

Completed

• Conditions: Rectal Cancer
• Interventions: Device: PET imaging with [18F]-FLT; Drug: [18F]-fluorodeoxythymidine

• Registration Number: NCT01207895
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-09-17
• Study First Submitted QC: 2010-09-21
• Study First Posted: 2010-09-23
• Primary Completion: 2012-12
• Study Completion: 2013-07
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-18
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]-FLT PET scans	PET imaging with [18F]-FLT	-
[18F]-FLT PET scans	[18F]-fluorodeoxythymidine	-

Primary Outcome Measures

Name	Time	Method
Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer	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

Name	Time	Method
Correlative biology	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

Trial Locations

Locations (1)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States