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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00416455
First received: December 27, 2006
Last updated: April 9, 2014
Last verified: April 2014
  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. 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.


Condition Intervention Phase
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
Drug: ferumoxtran-10
Procedure: diagnostic lymphadenectomy
Procedure: axillary lymph node biopsy
Procedure: 3-Tesla magnetic resonance imaging
Procedure: positron emission tomography/computed tomography
Radiation: fludeoxyglucose F 18
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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

Resource links provided by NLM:


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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Diagnostic sensitivity and specificity of preoperative ferumoxtran-10 MRI scanning [ Time Frame: Up to 5 years ] [ 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 [ Time Frame: Up to 5 years ] [ 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 [ Time Frame: Up to 5 years ] [ 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 [ Time Frame: Up to 5 years ] [ 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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer [ Time Frame: Up to 5 years ] [ 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 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events assessed by Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 380
Study Start Date: September 2007
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (diagnostic scans, sugery, chemotherapy, radiation)
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.
Drug: ferumoxtran-10
Other Names:
  • AMI-227
  • Combidex
  • G-53425
  • Sinerem
  • USPIO
Procedure: diagnostic lymphadenectomy Procedure: axillary lymph node biopsy
Other Name: axillary node biopsy
Procedure: 3-Tesla magnetic resonance imaging
Other Names:
  • 3-Tesla MRI
  • 3T MRI
Procedure: positron emission tomography/computed tomography Radiation: fludeoxyglucose F 18
Other Names:
  • 18FDG
  • FDG

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

    • Patients with endometrial cancer with known intraperitoneal disease are eligible provided they undergo pelvic and para-aortic lymphadenectomy per protocol
  • Participants must be enrolled at an American College of Radiology Imaging Network (ACRIN)-affiliated institution that is accredited by Gynecologic Oncology Group (GOG)
  • GOG performance status 0-2
  • Creatinine within normal institutional limits OR, in participants with creatinine levels above institutional normal, glomerular filtration rate (GFR) must be > 60 mL/min; there is no lower limit of normal for serum creatinine for this protocol
  • 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
  • No patients weighing greater than that allowable by the PET/CT scanner
  • 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)
  • 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

  Show 29 Study Locations
Sponsors and Collaborators
Investigators
Principal Investigator: Mostafa Atri Gynecologic Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00416455     History of Changes
Other Study ID Numbers: NCI-2009-00600, NCI-2009-00600, CDR0000521453, ACRIN 6671, GOG-0233, ACRIN-6671, GOG-0233-ACRIN 6671, GOG-0233/ACRIN 6671, GOG-0233, U10CA027469
Study First Received: December 27, 2006
Last Updated: April 9, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Carcinoma, Squamous Cell
Uterine Cervical Neoplasms
Neoplasm Metastasis
Small Cell Lung Carcinoma
Carcinoma, Small Cell
Carcinoma, Adenosquamous
Adenocarcinoma, Clear Cell
Adenomyoepithelioma
Cystadenocarcinoma, Serous
Endometrial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplastic Processes
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on April 17, 2014