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

NCT00574353 | Completed Results

• 1 other identifier: 07-151
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Keywords

colorectal cancer; 07-151

Outcome Measures

Primary Outcomes (1)

• Number of Participants Successfully Scanned Using F-FMISO-PET Imaging

  The uptake kinetics of \[18F\]-Fluoromisonidazole activity in the colorectal lesion was entered into a compartmental model to determine the rate constants of uptake (k1) and irreversible binding (k3) in the lesion on the PET scan at different times post injection. Also the tumor to background ratio was determine. A plot of k3 and TNB was plotted. This will help determine the Feasibility of a Non-invasive Method of Detecting Hypoxia, Using F-FMISO-PET Imaging in Colorectal Cancer Patients.

  Post injection between 0-30 min, and again at the nominal times of 90 min and 180 min

Secondary Outcomes (1)

• Number of Participants Who Had Blood Samples Collected

  Up to 180 minutes post injection

Study Arms (1)

1

EXPERIMENTAL

FMISO PET study.

Radiation: Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission

Interventions

Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission RADIATION

You will be scanned 2 to 3 times on the same day, but you will only be administered one dose of the FMISO tracer. The first scan will last about 30 minutes. Then you will have 1 to 3 hours to wait before you are scanned again. Some patients will undergo a second scan approximately one-and-a-half hours after the start of the first scan. This scan will last about 10 minutes. The final scan will occur between 2-4 hours after the start of the first scan. This final scan will also last about 10 minutes. During the PET scan, you may have a separate i.v. line put into your other arm so that we can take 2 to 3 blood samples. These samples will be less than half a teaspoon each. We are taking these blood samples to see how quickly FMISO leaves your blood stream. The first sample will be taken between 2 and 40 minutes after the FMISO is injected. The other two blood samples will be taken with each subsequent scan.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older
• Karnofsky performance status ≥ or = to 70

You may not qualify if:

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Dr. John Humm, PhD
• Organization: Memorial Sloan Kettering Cancer Center

hummj@MSKCC.ORG

212-639-7367

Study Officials

• John Humm, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 17, 2007
• Study Start: December 11, 2007
• Primary Completion: July 5, 2024
• Study Completion: July 5, 2024
• Last Updated: May 9, 2025
• Results First Posted: May 9, 2025

Record last verified: 2024-07

Locations

US (1)