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| Sponsors and Collaborators: |
American College of Radiology Imaging Network National Cancer Institute (NCI) Gynecologic Oncology Group |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00416455 |
Purpose
RATIONALE: Diagnostic procedures, such as a fludeoxyglucose F 18 positron emission tomography (PET) scan, computed tomography (CT) scan, and ferumoxtran-10 magnetic resonance imaging (MRI) scan, may help find lymph node metastasis in patients with cervical cancer.
PURPOSE: This phase I/II trial is studying how well fludeoxyglucose F 18 PET scan, CT scan, and ferumoxtran-10 MRI scan finds lymph node metastasis before undergoing chemotherapy and radiation therapy in patients with locally advanced cervical cancer.
| Condition | Intervention | Phase |
|
Cervical Cancer |
Drug: ferumoxtran-10 Drug: fludeoxyglucose F 18 Procedure: biopsy Procedure: computed tomography Procedure: laparoscopy Procedure: lymphadenectomy Procedure: magnetic resonance imaging Procedure: positron emission tomography Procedure: radionuclide imaging |
Phase I Phase II |
| MedlinePlus related topics: | CT Scans Cancer Cervical Cancer MRI Scans Nuclear Scans |
| Drug Information available for: | Fluorodeoxyglucose F18 Ferumoxtran-10 |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Open Label |
| Official Title: | Utility of Preoperative FDG-PET/CT and Ferumoxtran-10 MRI Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally Advanced (IB2, IIA ≥ 4 CM, IIB-IVA) Carcinoma of the Cervix |
| Estimated Enrollment: | 325 |
| Study Start Date: | September 2007 |
| Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients undergo fludeoxyglucose F 18-positron emission tomography (FDG-PET)/CT scanning on day 1. Patients also receive ferumoxtran-10 IV over 30-45 minutes on day 1 (or 24-36 hours before MRI) and undergo MRI on day 2.
Patients undergo extraperitoneal or laparoscopic pelvic and abdominal lymph node biopsy on day 16. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. All patients undergo chemoradiotherapy within 4 weeks of lymph node sampling.
After completion of study therapy, patients are followed at 6 weeks, 6 months, every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 325 patients will be accrued for this study.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed invasive carcinoma of the cervix meeting all of the following criteria:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness, including but not limited to, any of the following:
Ferritin levels ≤ 600 ng/mL OR saturation of transferrin level ≤ 50%
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |||||
| Jonsson Comprehensive Cancer Center at UCLA | Recruiting | ||||
| Los Angeles, California, United States, 90095-1781 | |||||
| Contact: Clinical Trials Office - Jonsson Comprehensive Cancer Center a 888-798-0719 | |||||
| United States, Minnesota | |||||
| Mayo Clinic Cancer Center | Recruiting | ||||
| Rochester, Minnesota, United States, 55905 | |||||
| Contact: Clinical Trials Office - All Mayo Clinic Locations 507-538-7623 | |||||
| United States, New York | |||||
| Mount Sinai Medical Center | Recruiting | ||||
| New York, New York, United States, 10029 | |||||
| Contact: Lale Kostakoglu 212-241-6500 | |||||
| United States, Oregon | |||||
| Williamette Gynecologic Oncology PC | Recruiting | ||||
| Portland, Oregon, United States, 97213 | |||||
| Contact: Paul R. Kucera, MD 503-561-5294 | |||||
| United States, Rhode Island | |||||
| Women and Infants Hospital of Rhode Island | Recruiting | ||||
| Providence, Rhode Island, United States, 02905 | |||||
| Contact: Clinical Trials Office - Women and Infants Hospital of Rhode I 401-274-1122 | |||||
| Canada, Ontario | |||||
| Edmond Odette Cancer Centre at Sunnybrook | Recruiting | ||||
| Toronto, Ontario, Canada, M4N 3M5 | |||||
| Contact: Mostafa Atri, MD, Dip, Epid 416-480-6100 ext. 1418 mostafa.atri@sunnybrook.ca | |||||
| American College of Radiology Imaging Network |
| National Cancer Institute (NCI) |
| Gynecologic Oncology Group |
| Study Chair: | Mostafa Atri, MD, Dip, Epid | Edmond Odette Cancer Centre at Sunnybrook |
| Investigator: | Farrokh Dehdashti, MD | Mallinckrodt Institute of Radiology at Washington University Medical Center |
| Study Chair: | Michael A. Gold, MD | Oklahoma University Cancer Institute |
| Investigator: | Wui-jin Koh, MD | Fred Hutchinson Cancer Research Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000521453, ACRIN-6671, GOG-0233 |
| First Received: | December 27, 2006 |
| Last Updated: | November 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00416455 |
| Health Authority: | Unspecified |
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