Know Cancer

or
forgot password

A Feasibility 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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer

Thank you

Trial Information

A Feasibility 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


Hypoxia is a characteristic feature of malignant solid tumors associated with poor prognosis
and resistance to chemotherapy and radiation. It has also been shown (6) that the presence
of hypoxia may reduce long-term survival post surgery. Hypoxia renders tumor cells up to
three times more resistant to ionizing radiation than aerobic cells. The presence of hypoxic
regions within tumors may be one factor leading to local failure after treatment with
standard pre-operative radiotherapy doses. If these regions could be identified and verified
using a non-invasive imaging technique prior to surgery, they could be specifically targeted
using sophisticated planning techniques such as intensity modulated radiation therapy (IMRT)
to deliver higher doses ionizing radiation with preoperative radiotherapy. Future studies
using IMRT to "dose paint" areas of hypoxia within tumors will build upon the results of
this feasibility study. Ultimately, by the delivery of differential dose of radiation to the
tumor, in combination with surgery, the local control rates of rectal cancer patients may
further be improved.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Outcome Measure:

the feasibility of a non-invasive method of detecting hypoxia, using F-FMISO-PET imaging in colorectal cancer patients.

Outcome Time Frame:

three times on the same day.

Safety Issue:

No

Principal Investigator

Jose Guillem, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-151

NCT ID:

NCT00574353

Start Date:

December 2007

Completion Date:

December 2014

Related Keywords:

  • Colorectal Cancer
  • colorectal cancer
  • 07-151
  • Rectal Neoplasms
  • Colorectal Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021