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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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[18F]-FLT PET scans

Group Type EXPERIMENTAL

PET imaging with [18F]-FLT

Intervention Type DEVICE

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.

[18F]-fluorodeoxythymidine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DEVICE

[18F]-fluorodeoxythymidine

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No