Complete title: MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix
|Research Study Number||8118|
|Principal Investigator||Nina Mayr, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Female
- Patients must have histologically confirmed stage IB2-IVA epithelial carcinoma of the cervix, including squamous cell, adeno-, and undifferentiated carcinoma, and excluding small cell/neuroendocrine carcinoma, who will undergo radiation therapy for cervical cancer with curative intent
- Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
- Patients who will undergo standard radiation therapy with concurrent cisplatin-based chemotherapy for cervical cancer
- Patients with no prior radiation therapy to the pelvis
- Patients with no contra-indications to magnetic resonance (MR) imaging
- Patients must have adequate renal function: glomerular filtration rate (GFR) > 30 mL/min/1.73 m^2; for the test-retest sub-study MRI, patients must have a GFR of > 60 mL/min/1.73m^2
- Ability to understand and the willingness to sign a written informed consent document
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Patients who have received any prior pelvic radiation therapy in the area of the tumor that precludes the delivery of a curative dose of pelvic radiation
- Medical contraindication to MR imaging (e.g. pacemakers, metallic implants, aneurysm clips, known contrast allergy to gadolinium contrast, pregnancy, nursing mothers, weight greater than 350 pounds, GFR < 30)
- Major medical or psychiatric illness that, in the investigator's opinion, would prevent completion of treatment, completion of the study protocol, or interfere with follow-up
- Life expectancy of less than 6 months
Other exclusion criteria may apply.
Cervical Cancer; Gynecological Cancer; Solid Tumors; Uterine Cancer; Urogenital Neoplasms; Carcinoma, Squamous Cell; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Genital Neoplasms, Female; Carcinoma
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