N/A Completed N=23 Screening

Study Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography to Detect Hypoxia in Locally Advanced (T3-T4 and./or N1)Primary Rectal Cancer Patients

Colorectal Cancer

Source: ClinicalTrials.gov NCT00574353 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcomePrimary: Number of Participants Successfully Scanned Using F-FMISO-PET Imaging — 18; 5 Participants

Summary

When used with a different radioactive tracer called FMISO, a PET scan can find areas of low oxygen in the tumor. We think that having areas of low oxygen is a reason why some tumors are hard to treat with radiation. In a past study, FMISO PET scans were performed in 6 patients with rectal cancer that could not be operated on and that had spread to other areas. In this group of patients, FMISO PET scans were able to find the low oxygen areas in their tumors. But this study included only a few patients. In the present study, we want to use FMISO PET scans in patients who have tumors that can be operated on. This group of patients will have radiation, chemotherapy or both before they have their surgery. We want to see if FMISO PET can find low oxygen areas in this distinct group of patients.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Successfully Scanned Using F-FMISO-PET Imaging	18; 5	—
SECONDARY Number of Participants Who Had Blood Samples Collected	10; 13	—

Eligibility Criteria

Inclusion Criteria

Able to provide written informed consent
Histologically confirmed diagnosis of Stage 2 or Stage 3 rectal carcinoma requiring preoperative radiation, chemotherapy or both, per treating physician
18 years of age or older
Karnofsky performance status ≥ or = to 70

Exclusion Criteria

Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding

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Data sourced from ClinicalTrials.gov (NCT00574353). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.