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Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins

Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01189877
Enrollment
30
Registered
2010-08-27
Start date
2010-08-31
Completion date
2012-10-31
Last updated
2012-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Direct pO2 Measurements, 10-121

Brief summary

The purpose of this study is to see if the cells in rectal cancer are oxygen-starved, or hypoxic. We know that as cancers grow bigger, parts of them are cut off from the oxygen supply and they become hypoxic, basically, lacking oxygen. Research has shown that cells that are oxygen-starved respond differently to treatment such as chemotherapy and radiation when compared to cells that are oxygen rich.

Interventions

PROCEDUREEppendorf hypoximeter

Patients consented to the protocol will proceed to their surgery date without any change in the standard preoperative period. After arriving in the operating room, the patient will undergo intravenous general anesthesia (or spinal/epidural anesthesia) by the anesthesiologist and will receive 40% oxygen. At this time, the principal investigator (along with the assistance of the operating surgeon and a member of the Department of Medical Physics) will use the Eppendorf hypoximeter to gather pO2 measurements. We anticipate that this will add no more than fifteen minutes to the planned procedure. Once the measurements are collected, the anesthesia will be adjusted as appropriate for the surgery and the procedure will continue as usual.

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

* Biopsy proven adenocarcinoma of the rectum. If a biopsy was taken at an outside hospital, the slides and diagnosis will be reviewed and confirmed by a pathologist at MSKCC. * Mid to distal rectal tumors not requiring pre-op radiation or chemotherapy * Age ≥ 18 * Age \< 90 * Karnofsky performance status ≥ 60 * Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

* Current pregnancy * Uncontrolled intercurrent illness that would limit compliance with study requirements.

Design outcomes

Primary

MeasureTime frameDescription
Measure pO2 in rectal cancers2 yearsMeasure pO2 in rectal cancers

Secondary

MeasureTime frameDescription
Correlate immunohistochemical analysis of endogenous markers of hypoxia2 yearswith direct tumor hypoximetry in tumor and normal tissue.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026