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Fludeoxyglucose (FDG) F 18 PET Scan, CT Scan, and Ferumoxtran-10 MRI Scan Before Chemotherapy and Radiation Therapy in Finding Lymph Node Metastasis in Patients With Locally Advanced Cervical Cancer or High-Risk Endometrial Cancer

Recruiting in Palo Alto (17 mi)
+32 other locations
MA
Overseen byMostafa Atri
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Waitlist Available
Sponsor: National Cancer Institute (NCI)
No Placebo Group

Trial Summary

What is the purpose of this trial?

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 or high-risk endometrial cancer. 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 or endometrial cancer.

Research Team

MA

Mostafa Atri

Principal Investigator

NRG Oncology

Eligibility Criteria

Inclusion Criteria

Previously untreated, primary disease
Locoregionally advanced (stage IB2, IIA [>= 4 cm], or IIB-IVA) disease
Any cell type allowed
See 7 more

Treatment Details

Interventions

  • Computed Tomography (Procedure)
  • Ferumoxtran-10 (Contrast Agent)
  • Fludeoxyglucose F 18 (Radiation)
  • Magnetic Resonance Imaging (Procedure)
  • Positron Emission Tomography (Procedure)
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Treatment (diagnostic scans, surgery, chemotherapy, radiation)Experimental Treatment7 Interventions
Patients receive fludeoxyglucose F 18 (FDG) IV followed 60 minutes later by positron emission tomography (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, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan. Patients diagnosed with metastatic disease prior to lymph node biopsy proceed directly to primary treatment. Patients with cervical cancer undergo chemoradiotherapy within 4 weeks of PET/CT scan.

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials
14,080
Recruited
41,180,000+
Dr. Douglas R. Lowy profile image

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli profile image

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

NRG Oncology

Collaborator

Trials
242
Recruited
105,000+
Stephanie Gaillard profile image

Stephanie Gaillard

NRG Oncology

Chief Medical Officer

MD from Johns Hopkins University

Norman Wolmark

NRG Oncology

Chief Executive Officer since 2023

MD from Harvard Medical School