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

NCT00416455 | Completed Phase 1 Results

• 8 other identifiers: NCI-2009-00600CDR0000521453ACRIN 6671GOG-0233/ACRIN 6671GOG-0233-ACRIN 6671GOG-0233U10CA180868U10CA027469
• Study Type: interventional
• Target: 384
• Locations: 4 countries
• Sites: 33

Brief 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.

Conditions

Cervical 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

Outcome Measures

Primary Outcomes (2)

• The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen

  The sensitivity is defined as the percentage of patients who test with lymph node metastases by pre-operative PET/CT among the patients who have lymph node metastases identified by post-surgery pathology in abdomen. The reported sensitivity is reader average sensitivity by seven experienced PET-CT readers.

  Before surgery (FDG-PET-CT) and after surgery (pathology)

• The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen

  The specificity is defined as the percentage of patients who test without lymph node metastases by pre-operative PET/CT among the patients who do not have lymph node metastases identified by post-surgery pathology in abdomen. The reported specificity is reader average specificity by seven experienced PET-CT readers.

  Before surgery (FDG-PET/CT) and after surgery (pathology)

Secondary Outcomes (15)

• The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis

  Before surgery (DCT) and after surgery (pathology)

• The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Pelvis

  Before surgery (FDG-PET/CT) and after surgery (pathology)

• The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis

  Before surgery (FDG-PET/CT) and after surgery (pathology)

• The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis

  Before surgery (FDG-PET/CT) and after surgery (pathology)

• Sensitivity for Detection of Lymph Node Metastasis in Abdomen by CT Alone

  Before surgery (FDG-PET/CT) and after surgery (pathology)

Study Arms (1)

Treatment (diagnostic scans, surgery, chemotherapy, radiation)

EXPERIMENTAL

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.

Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Procedure: computed tomography; Drug: ferumoxtran-10; Procedure: magnetic resonance imaging; Procedure: diagnostic lymphadenectomy; Procedure: lymph node biopsy

Interventions

fludeoxyglucose F 18 RADIATION

Undergo FDG PET/CT

Also known as: 18FDG, FDG

Treatment (diagnostic scans, surgery, chemotherapy, radiation)

positron emission tomography PROCEDURE

Undergo FDG PET/CT

Also known as: FDG-PET, PET, PET scan, tomography, emission computed

Treatment (diagnostic scans, surgery, chemotherapy, radiation)

computed tomography PROCEDURE

Undergo FDG PET/CT

Also known as: tomography, computed

Treatment (diagnostic scans, surgery, chemotherapy, radiation)

ferumoxtran-10 DRUG

Undergo femoxtran-10 MRI

Also known as: AMI-227, Combidex, G-53425, Sinerem, USPIO

Treatment (diagnostic scans, surgery, chemotherapy, radiation)

magnetic resonance imaging PROCEDURE

Undergo femoxtran-10 MRI

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Treatment (diagnostic scans, surgery, chemotherapy, radiation)

diagnostic lymphadenectomy PROCEDURE

Undergo extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy

Treatment (diagnostic scans, surgery, chemotherapy, radiation)

lymph node biopsy PROCEDURE

Undergo pelvic and abdominal lymph node biopsy

Also known as: Biopsy of Lymph Node

Treatment (diagnostic scans, surgery, chemotherapy, radiation)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed diagnosis of 1 of the following:
• Invasive carcinoma of the cervix meeting all of the following criteria:
• Previously untreated, primary disease
• Locoregionally advanced (stage IB2, IIA \[\>= 4 cm\], or IIB-IVA) disease
• Any cell type allowed
• High-risk endometrial carcinoma meeting 1 of the following criteria:
• Grade 3 endometrioid or non-endometrioid endometrial carcinoma (clear cell or serous papillary) or carcinosarcoma diagnosed from an endometrial biopsy or dilation and curettage or
• Grade 1 or 2 endometrioid endometrial carcinoma with cervical stromal involvement overt on clinical examination or confirmed by endocervical curettage
• Under consideration for chemoradiotherapy (patients with cervical cancer)
• Undergone appropriate surgery for cervical or endometrial carcinoma with appropriate tissue available for histologic evaluation to confirm diagnosis and stage
• Appropriate surgical candidate to undergo extraperitoneal or laparoscopic lymph node sampling OR hysterectomy and lymph node sampling
• No surgery for patients with advanced lymphadenopathy
• No recurrent invasive carcinoma of the uterus or uterine cervix regardless of previous treatment
• No known metastases to the lungs or scalene lymph nodes
• No metastases to other organs outside of the pelvis or abdominal lymph nodes at the time of the original clinical diagnosis

Sponsors & Collaborators

• National Cancer Institute (NCI): lead
• NRG Oncology: collaborator

Study Sites (33)

Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

University of California at Los Angeles Health System

Los Angeles, California, 90095, United States

Location

Olive View-University of California Los Angeles Medical Center

Sylmar, California, 91342, United States

Location

The Hospital of Central Connecticut

New Britain, Connecticut, 06050, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Georgia Regents University Medical Center

Augusta, Georgia, 30912, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

UMDNJ - New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Island Gynecologic Oncology

Brightwaters, New York, 11718, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Weill Medical College of Cornell University

New York, New York, 10065, United States

Location

Montefiore Medical Center-Einstein Campus

The Bronx, New York, 10461, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Providence Cancer Center -The Plaza

Portland, Oregon, 97213, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

Women and Infants Hospital

Providence, Rhode Island, 02905, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

CHUQ - Pavilion Hotel-Dieu de Quebec

Québec, Quebec, G1R 2J6, Canada

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Kagoshima City Hospital

Kagoshima City, Kagoshima, 892-8580, Japan

Location

Saitama Medical University International Medical Center

Saitama, 350-1298, Japan

Location

Keimyung University-Dongsan Medical Center

Jung-Ku, Daegu, 700-712, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Gangnam Severance Hospital

Seoul, 135-720, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Korea Cancer Center Hospital

Seoul, 139-706, South Korea

Location

MeSH Terms

Conditions

Endometrial Neoplasms; Uterine Cervical Neoplasms

Interventions

Fluorodeoxyglucose F18; Magnetic Resonance Spectroscopy; 2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole; ferumoxtran-10; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision

Limitations and Caveats

Relatively small number of patients with abdominal metastasis in both cervical and endometrial cancer cohorts

Results Point of Contact

• Title: Angela M. Kuras, Associate Director of Data Management
• Organization: NRG Oncology Statistics and Data Management Center

kurasa@nrgoncology.org

716-845-7733

Study Officials

• Mostafa Atri

  NRG Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2006
• First Posted: December 28, 2006
• Study Start: September 1, 2007
• Primary Completion: September 1, 2014
• Study Completion: July 16, 2016
• Last Updated: July 23, 2019
• Results First Posted: December 14, 2015

Record last verified: 2018-11

Locations

US (24); JP (3); KR (5); CA (1)