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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01207895
• Other study ID #: VICC GI 0993
• Status: Completed
• Phase: Phase 1
• First received: September 17, 2010
• Last updated: February 18, 2017
• Start date: March 2010
• Est. completion date: July 2013

Study information

• Verified date: February 2017
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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.

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

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	at study entry before treatment, at week 3 of treatment, and at week 11 after treatment

External Links

•   Vanderbilt-Ingram Cancer Center, Find a Clinical Trial