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Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer


N/A
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer

Thank you

Trial Information

Tumor Perfusion and Hypoxia Assessed by DCE-MRI and 18F-FMISO PET as Biomarkers of Treatment Response in Cervical Cancer


Inclusion Criteria:



- Biopsy-documented, newly-diagnosed primary cervical cancer of all histopathology
types.

- Clinically visible gross lesion (International Federation of Gynecology and
Obstetrics (FIGO) stage IB1 and above).

- Treatment (chemoradiation), DCE-MRI and 18F-FMISO PET studies will be at MSKCC.

- Patients must be an adult female 18 years of age or older.

Exclusion Criteria:

- Patients who because of general medical or psychiatric condition, or physiologic
status cannot give an informed consent.

- Patients who received prior radiation treatment to pelvis.

- Patients with contraindications to DCE-MRI (non-compatible cardiac pacemakers or
intracranial vascular clips, allergy to Gadolinium, end-stage renal disease) and/or
18F-FMISO PET.

- Patients who do not fulfill the screening criteria for safe DCE-MRI or 18F-FMISO PET
as per the Department of Radiology guidelines.

- Pregnant patients; and or patients who are breast-feeding their babies.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

predict tumor response

Outcome Description:

For each DCE-MRI parameter, the relative percent change from baseline to the two-week measurement will be calculated. These values will be assessed using ROC curves to evaluate whether they are predictive of tumor response.

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Oguz Akin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-174

NCT ID:

NCT01613521

Start Date:

June 2012

Completion Date:

June 2014

Related Keywords:

  • Cervical Cancer
  • DCE-MRI
  • 18F-FMISO PET
  • 11-174
  • Uterine Cervical Neoplasms
  • Anoxia

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021