CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 384 enrolled
Drug / intervention
ferumoxtran-10 +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00416455
NCT00416455Phase 2Completed
CompareCT.gov

Utility of Preoperative FDG-PET/CT Scanning Prior to Primary Chemoradiation Therapy to Detect Retroperitoneal Lymph Node Metastasis in Patients With Locoregionally Advanced Carcinoma of the Cervix (IB2, IIA ≥ 4 CM, IIB-IVA) or Endometrium (Grade 3 Endometrioid Endometrial Carcinoma; Serous Papillary Carcinoma, Clear Cell Carcinoma, or Carcinosarcoma (Any Grade); and Grade 1 OR 2 Endometrioid Endometrial Carcinoma With Cervical Stromal Involvement Overt in Clinical Examination or Confirmed by Endocervical Curettage

National Cancer Institute (NCI)·interventional·Posted Dec 28, 2006·Updated Jul 23, 2019

In Brief

A Phase 2 clinical trial evaluating fludeoxyglucose F 18, positron emission tomography, and 5 other interventions for Cervical Adenocarcinoma and 13 related conditions. Completed, enrolled 384 participants across 33 sites in 4 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCervical Adenocarcinoma, Cervical Adenosquamous Cell Carcinoma, Cervical Small Cell Carcinoma, Cervical Squamous Cell Carcinoma, Endometrial Clear Cell Carcinoma, Endometrial Papillary Serous Carcinoma, Stage I Endometrial Carcinoma, Stage IB Cervical Cancer, Stage II Endometrial Carcinoma, Stage IIA Cervical Cancer, Stage IIB Cervical Cancer, Stage III Cervical Cancer, Stage III Endometrial Carcinoma, Stage IVA Cervical Cancer
CountriesCanada, Japan, South Korea, United States
CollaboratorsNRG Oncology

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 28, 2006
Enrollment StartSep 1, 2007
Primary CompletionSep 1, 2014
Study CompletionJul 16, 2016
TodayJul 2, 2026
Enrollment to primary: 7 yearsPosted 19.5 years ago

Interventions

fludeoxyglucose F 18radiation

Undergo FDG PET/CT

positron emission tomographyprocedure

Undergo FDG PET/CT

computed tomographyprocedure

Undergo FDG PET/CT

ferumoxtran-10drug

Undergo femoxtran-10 MRI

magnetic resonance imagingprocedure

Undergo femoxtran-10 MRI

diagnostic lymphadenectomyprocedure

Undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy

lymph node biopsyprocedure

Undergo pelvic and abdominal lymph node biopsy