Fludeoxyglucose 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 - Full Text View

Sponsor:	American College of Radiology Imaging Network
Collaborators:	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 or endometrial 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 or high-risk endometrial cancer.

Condition	Intervention	Phase
Cervical Cancer Endometrial Cancer	Drug: ferumoxtran-10 Procedure: diagnostic lymphadenectomy Procedure: lymph node biopsy Procedure: lymphadenectomy Procedure: magnetic resonance imaging Procedure: positron emission tomography/computed tomography Radiation: fludeoxyglucose F 18	Phase I Phase II

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 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

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer MRI Scans Nuclear Scans

Drug Information available for: Fluorodeoxyglucose F18 Ferumoxtran-10

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning [ Designated as safety issue: No ]
Diagnostic sensitivity and specificity of preoperative ferumoxtran-10 MRI scanning [ Designated as safety issue: No ]

Secondary Outcome Measures:

Comparison of the diagnostic sensitivity and specificity of PET/CT scan vs PET scanning alone in identifying metastases to pelvic, abdominal, and combined (all regions) lymph nodes [ Designated as safety issue: No ]
Comparison of the diagnostic sensitivity and specificity of ferumoxtran-10 MRI vs MRI alone, in terms of size criteria in the abdomen and pelvis [ Designated as safety issue: No ]
Percentage of patients with locoregionally advanced cervical cancer or high-risk endometrial cancer who have biopsy-proven disease outside the abdominal or pelvic lymph nodes detected by PET/CT scanning [ Designated as safety issue: No ]
Accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer [ Designated as safety issue: No ]
Complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer [ Designated as safety issue: No ]
Cause(s) of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer [ Designated as safety issue: No ]
Adverse events, including those associated with ferumoxtran-10 [ Designated as safety issue: Yes ]

Estimated Enrollment:	380
Study Start Date:	September 2007
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to abdominal (common iliac, para-aortic, and paracaval) lymph nodes in patients with locoregionally advanced cervical carcinoma.
Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to retroperitoneal abdominal lymph nodes in patients with high-risk endometrial cancer.

Secondary

Determine the diagnostic sensitivity and specificity of preoperative FDG-PET/CT scanning and ferumoxtran-10 MRI scanning in identifying metastases to pelvic lymph nodes and pelvic and abdominal lymph nodes combined in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
Compare the additive diagnostic value of CT fusion (PET/CT scan) vs PET scanning alone in identifying metastases to pelvic, abdominal, and combined (all regions) lymph nodes in these patients.
Compare the diagnostic sensitivity and specificity of PET/CT scanning vs ferumoxtran-10 MRI scanning in identifying metastases to pelvic, abdominal, and combined lymph nodes in these patients.
Compare the diagnostic sensitivity and specificity of ferumoxtran-10 MRI vs MRI alone, in terms of size criteria in the abdomen and pelvis, in these patients.
Determine the percentage of patients with locoregionally advanced cervical cancer or high-risk endometrial cancer who have biopsy-proven disease outside the abdominal or pelvic lymph nodes detected by PET/CT scanning.
Determine the accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer.
Determine the complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer.
Determine the cause(s) of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer.
Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer.
Compare the size of lymph nodes in pre- and post-ferumoxtran-10 MRI's in a subset of forty patients.

OUTLINE: This is a multicenter study.

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.

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 380 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

Criteria

DISEASE CHARACTERISTICS:

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
  - 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)
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
- Patients with endometrial cancer with known intraperitoneal disease are eligible provided they undergo pelvic and para-aortic lymphadenectomy per protocol

PATIENT CHARACTERISTICS:

GOG performance status 0-2
Creatinine normal OR creatinine clearance > 60 mL/min
Ferritin levels ≤ 600 ng/mL OR saturation of transferrin level ≤ 50%
- Patients with high levels of ferritin or transferrin are eligible if documented hematology rules out iron overload
Not pregnant or nursing
Negative pregnancy test
Weight ≤ 300 lbs
No renal abnormalities, such as a pelvic kidney, horseshoe kidney, or renal transplantation, that would require modification of the lymphadenectomy
No history of anaphylactic or life-threatening allergic reactions to any contrast media
No other invasive malignancies within the past 5 years with the exception of nonmelanoma skin cancer
No contraindication to MRI (e.g., severe claustrophobia, pacemaker, aneurysm clips, defibrillators, or other institutional contraindication to MRI)
No history of allergic reactions attributed to compounds of similar chemical or biological composition to ferumoxtran-10 (e.g., iron preparations, parenteral iron, parenteral dextran, parenteral iron-dextran, or parenteral iron-polysaccharide preparations)
No immunodeficiencies that would predispose patient to specific or nonspecific mediator release
No history of cirrhosis
No poorly controlled, insulin-dependent diabetes (i.e., fasting blood glucose level > 200 mg/dL)

PRIOR CONCURRENT THERAPY:

No prior pelvic or abdominal lymphadenectomy
No prior pelvic radiotherapy
No prior anticancer therapy that would contraindicate study participation
No ferumoxides within the past 2 weeks
No investigational agents within the past 30 days
No other concurrent investigational agents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416455

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
Olive View - UCLA Medical Center Foundation	Recruiting
Sylmar, California, United States, 91342
Contact: Christine Holschneider, MD 310-206-5161
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, Oklahoma
Oklahoma University Cancer Institute	Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Robert S. Mannel, MD 405-271-8787
United States, Pennsylvania
Fox Chase Cancer Center - Philadelphia	Recruiting
Philadelphia, Pennsylvania, United States, 19111-2497
Contact: Clinical Trials Office - Fox Chase Cancer Center - Philadelphi 215-728-4790
Canada, Ontario
Edmond Odette Cancer Centre at Sunnybrook	Recruiting
Toronto, Ontario, Canada, M5G 2N2
Contact: Mostafa Atri, MD, Dip, Epid 416-340-4800 ext 3253

Sponsors and Collaborators

American College of Radiology Imaging Network

National Cancer Institute (NCI)

Gynecologic Oncology Group

Investigators

Study Chair:	Mostafa Atri, MD, Dip, Epid	Toronto General Hospital
Investigator:	Farrokh Dehdashti, MD	Mallinckrodt Institute of Radiology at Washington University Medical Center
Study Chair:	Michael A. Gold, MD	Vanderbilt Medical Group & Clinic at Vanderbilt Medical Center
Investigator:	Wui-jin Koh, MD	Fred Hutchinson Cancer Research Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Gynecologic Oncology Group ( Philip J. DiSaia )
Study ID Numbers:	CDR0000521453, ACRIN-6671, GOG-0233
Study First Received:	December 27, 2006
Last Updated:	November 13, 2009
ClinicalTrials.gov Identifier:	NCT00416455 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cervical adenocarcinoma
cervical adenosquamous cell carcinoma
cervical small cell carcinoma
cervical squamous cell carcinoma
stage IB cervical cancer
stage IIA cervical cancer
stage IIB cervical cancer

stage III cervical cancer
stage IVA cervical cancer
endometrial clear cell carcinoma
endometrial papillary carcinoma
stage I endometrial carcinoma
stage II endometrial carcinoma
stage III endometrial carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Genital Neoplasms, Female
Uterine Diseases
Urogenital Neoplasms
Carcinoma
Genital Diseases, Female
Endometrial Neoplasms
Neoplasms
Neoplastic Processes

Neoplasms by Site
Adenocarcinoma, Clear Cell
Pathologic Processes
Carcinoma, Papillary
Neoplasm Metastasis
Uterine Neoplasms
Neoplasms, Squamous Cell
Adenocarcinoma
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009