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

NCT01207895 | Completed Phase 1 DMC

• 1 other identifier: VICC GI 0993
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery

Secondary Outcomes (1)

• Correlative biology

  at study entry before treatment, at week 3 of treatment, and at week 11 after treatment

Study Arms (1)

[18F]-FLT PET scans

EXPERIMENTAL

Device: PET imaging with [18F]-FLT; Drug: [18F]-fluorodeoxythymidine

Interventions

PET imaging with [18F]-FLT 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]-FLT PET scans

[18F]-fluorodeoxythymidine DRUG

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

[18F]-FLT PET scans

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with known rectal cancer.
• Subjects must have signed an approved consent form.
• Subjects must be 18 years of age or older.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead

Study Sites (1)

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Vanderbilt-Ingram Cancer Center, Find a Clinical Trial

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Henry Manning, Ph.D.

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Radiology, Neurosurgery, Biomedical Engineering, Program in Chemical and Physical Biology

Study Record Dates

• First Submitted: September 17, 2010
• First Posted: September 23, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: July 1, 2013
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

US (1)