Clinical trial · Interventional
Molecular Determinants Affecting Fluoro-L-thymidine (FLT) Positron Emission Tomography (PET) in Rectal Cancer
NCT01207895CI-TRIAL-00026067completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]-fluorodeoxythymidine | Drug | — | UNRESOLVED |
| PET imaging with [18F]-FLT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]-FLT PET scans
- interventionNames
- Device: PET imaging with [18F]-FLT
- Drug: [18F]-fluorodeoxythymidine
Primary outcomes (1)
- measure
- Utility of [18F]-FLT PET to assess cellular proliferation in neoadjuvant trials of patients with rectal cancer
- timeFrame
- at study entry, at week 3 during chemotherapy and radiation, and at week 11 after treatment but before surgery
- description
- Ability of this imaging technique to determine growth of cancer cells and as a quantitative biomarker of response to relevant, molecularly targeted, therapies
Secondary outcomes (1)
- measure
- Correlative biology
- timeFrame
- at study entry before treatment, at week 3 of treatment, and at week 11 after treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.