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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 33
- 主要终点
- The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVES:
I. 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.
II. 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 OBJECTIVES:
I. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Treatment (diagnostic scans, surgery, 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.
干预措施: fludeoxyglucose F 18 (Radiation)
Treatment (diagnostic scans, surgery, 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.
干预措施: positron emission tomography (Procedure)
Treatment (diagnostic scans, surgery, 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.
干预措施: computed tomography (Procedure)
Treatment (diagnostic scans, surgery, 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.
干预措施: ferumoxtran-10 (Drug)
Treatment (diagnostic scans, surgery, 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.
干预措施: magnetic resonance imaging (Procedure)
Treatment (diagnostic scans, surgery, 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.
干预措施: diagnostic lymphadenectomy (Procedure)
Treatment (diagnostic scans, surgery, 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.
干预措施: lymph node biopsy (Procedure)
结局指标
主要结局
The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
时间窗: Before surgery (FDG-PET-CT) and after surgery (pathology)
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.
The Diagnostic Specificity of PET/CT for Detection of Lymph Node Metastasis in Abdomen
时间窗: Before surgery (FDG-PET/CT) and after surgery (pathology)
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.
次要结局
- 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))
- Sensitivity for Detection of Lymph Node Metastasis in Pelvis by CT Alone(Before surgery (FDG-PET/CT) and after surgery (pathology))
- Specificity Between for Detection of Lymph Node Metastasis in Pelvis by CT Alone(Before surgery (FDG-PET/CT) and after surgery (pathology))
- Cervical Cancer Patients With Adverse Events (Grade 3 or Higher) at Least Possibly Attributed to Extra-peritoneal or Laparoscopic Abdominal and Pelvic Lymphadenectomy(During surgery and up to 30 days after surgery.)
- 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 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))
- Cause of Interruption in Radiation Therapy in Cervical Cancer Patients(Within 6 weeks after surgery)
- The Diagnostic Sensitivity of PET/CT for Detection of Lymph Node Metastasis in Pelvis(Before surgery (DCT) and after surgery (pathology))
- Sensitivity Between for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone(Before surgery (FDG-PET/CT) and after surgery (pathology))
- Cause of Delay in the Initiation of Chemo-radiation Therapy More Than 4 Weeks After PET/CT for Cervical Cancer Patients(Within 4 weeks from PET/CT)
- Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Abdominal Lymph Nodes(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))
- Specificity for Detection of Lymph Node Metastasis in Abdomen by CT Alone(Before surgery (FDG-PET/CT) and after surgery (pathology))
- Specificity for Detection of Lymph Node Metastasis in Combination of Abdomen and Pelvis by CT Alone(Before surgery (FDG-PET/CT) and after surgery (pathology))
- Percentage of Participants in Whom PET/CT Detects Biopsy-proven Disease Outside the Pelvic Lymph Node(Before surgery (FDG-PET/CT) and after surgery (pathology))