A Phase 1 interventional study of PET imaging with [18F]-FLT and [18F]-fluorodeoxythymidine in Rectal Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-02-23.
Sponsored by Vanderbilt-Ingram Cancer Center · Phase 1, Interventional, and Basic science
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.
1,762 studies on the registry are indexed under Rectal Neoplasms; 518 are open to participants now.
This study's enrollment of 5 is below the median of 65 across 1,298 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
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Exclusion Criteria:
Device: PET imaging with [18F]-FLT · Drug: [18F]-fluorodeoxythymidine
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 is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
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
Time frame: at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery
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
Time frame: at study entry before treatment, at week 3 of treatment, and at week 11 after treatment
This study is completed, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Vanderbilt-Ingram Cancer Center