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Cancer trials
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Trial details

MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix

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Trial short name: MRI-PET Cervix

Official title: MRI- and PET-Predictive-Assay of Treatment Outcome in Cancer of the Cervix

Principal Investigator: Dr. Eric Leung

Cancer type: Gynecology
Cancer location: Cervix
Disease stage: Early Cancer
Trial phase: Other
Intervention: Other: Imaging

Registration #: NCT01992861

Trial description:
The purpose of this study is to look at magnetic resonance imaging (MRI) and positron emission tomography (PET) scans to assist treatment plans in patients with cervical cancer. Patients with cervical cancer who are to have radiation therapy and chemotherapy may be able to participate. All patients participating in the study will receive their radiation therapy and chemotherapy as per standard treatment and will undergo additional MRI and PET scans throughout their treatment. By comparing the results of these scans before, during and after treatment doctors may be better able to predict a patient’s response to treatment and plan the best treatment.

Inclusion Criteria: • 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 Exclusion Criteria: • Patients with small cell/neuroendocrine cervical carcinoma • 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