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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Completed

Conditions: Rectal Cancer

Treatments: Procedure: Eppendorf hypoximeter

Study type: Interventional

Funder types: Other

Identifiers

NCT01189877

10-121

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

pO2 measurements

Experimental group

Description:

In patients meeting eligibility requirements outlined below, comparisons will be made between direct pO2 measurements using a tissue hypoximeter and IHC-assessed expression of hypoxia related proteins (HIF-1α, VEGF, CA IX and GLUT-1) in both normal and tumor tissue.

Treatment:

Procedure: Eppendorf hypoximeter