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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Henry C. Manning, PhD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT01207895
First received: September 17, 2010
Last updated: January 17, 2014
Last verified: January 2014

September 17, 2010
January 17, 2014
March 2010
December 2013   (final data collection date for primary outcome measure)
Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer [ Time Frame: at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery ] [ Designated as safety issue: No ]
Ability of this imaging technique to determine growth of cancer cells and as a quantitative biomarker of response to relevant, molecularly targeted, therapies
18F-fluorodeoxythymidine Positron Emission Tomography in neoadjuvant trials of patients with rectal cancer cancer. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01207895 on ClinicalTrials.gov Archive Site
Correlative biology [ Time Frame: at study entry before treatment, at week 3 of treatment, and at week 11 after treatment ] [ Designated as safety issue: No ]
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
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Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer

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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Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Rectal Cancer
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.
Experimental: [18F]-FLT PET scans
Intervention: Device: PET imaging with [18F]-FLT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
5
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01207895
VICC GI 0993
Yes
Henry C. Manning, PhD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
Not Provided
Principal Investigator: Henry Manning, Ph.D. Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP