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
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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 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 |
- 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 ]
- 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: | January 2100 (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.
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Drug: ferumoxtran-10
Other Names:
Procedure: diagnostic lymphadenectomy
Procedure: axillary lymph node biopsy
Other Name: axillary node biopsy
Procedure: 3-Tesla magnetic resonance imaging
Other Names:
Procedure: positron emission tomography/computed tomography
Radiation: fludeoxyglucose F 18
Other Names:
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Show Detailed Description
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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
- 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 ACRIN-affiliated institution that is accredited by 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
Show 26 Study Locations
Principal Investigator: | Mostafa Atri | Gynecologic Oncology Group |
No publications provided
Responsible Party: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00416455 History of Changes |
Other Study ID Numbers: | NCI-2009-00600, U10CA080098, CDR0000521453, GOG-0233 |
Study First Received: | December 27, 2006 |
Last Updated: | September 19, 2012 |
Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Carcinoma, Squamous Cell Uterine Cervical Neoplasms Neoplasm Metastasis Small Cell Lung Carcinoma Carcinoma, Small Cell Carcinoma, Adenosquamous Adenocarcinoma, Clear Cell Adenomyoepithelioma Cystadenocarcinoma, Serous Adenoma Endometrial Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous 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 |
ClinicalTrials.gov processed this record on February 14, 2013