Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416455
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2006-12-27
Brief Title:
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
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Utility of Preoperative FDG-PETCT 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
Status:
COMPLETED
Status Verified Date:
2018-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III 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
Detailed Description:
PRIMARY OBJECTIVES
I Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography FDG-PETCT 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-PETCT 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-PETCT 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
II Compare the additive diagnostic value of CT fusion PETCT scan vs PET scanning alone in identifying metastases to pelvic abdominal and combined all regions lymph nodes in these patients
III Compare the diagnostic sensitivity and specificity of PETCT scanning vs ferumoxtran-10 MRI scanning in identifying metastases to pelvic abdominal and combined lymph nodes in these patients
IV 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
V 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 PETCT scanning
VI Determine the accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer
VII Determine the complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer
VIII Determine the causes of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer
IX Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer
X Compare the size of lymph nodes in pre- and post-ferumoxtran-10 MRIs 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 PETCT 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 PETCT 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 PETCT 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
I Determine the diagnostic sensitivity and specificity of preoperative fludeoxyglucose F 18 positron emission tomography FDG-PETCT 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-PETCT 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-PETCT 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
II Compare the additive diagnostic value of CT fusion PETCT scan vs PET scanning alone in identifying metastases to pelvic abdominal and combined all regions lymph nodes in these patients
III Compare the diagnostic sensitivity and specificity of PETCT scanning vs ferumoxtran-10 MRI scanning in identifying metastases to pelvic abdominal and combined lymph nodes in these patients
IV 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
V 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 PETCT scanning
VI Determine the accuracy of MRI in determining the depth of myometrial invasion and involvement of cervix in patients with high-risk endometrial cancer
VII Determine the complications associated with extraperitoneal or laparoscopic abdominal and pelvic lymphadenectomy in patients with locoregionally advanced cervical cancer
VIII Determine the causes of delay in the initiation of radiotherapy or interruption in radiotherapy in patients with locoregionally advanced cervical cancer
IX Collect data on the adverse effects of ferumoxtran-10 in patients with locoregionally advanced cervical carcinoma or high-risk endometrial cancer
X Compare the size of lymph nodes in pre- and post-ferumoxtran-10 MRIs 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 PETCT 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 PETCT 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 PETCT 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA027469 | NIH | CTEP | httpsreporternihgovquickSearchU10CA027469 |
| NCI-2009-00600 | REGISTRY | None | None |
| CDR0000521453 | None | None | None |
| ACRIN 6671 | None | None | None |
| GOG-0233ACRIN 6671 | None | None | None |
| GOG-0233-ACRIN 6671 | OTHER | None | None |
| GOG-0233 | OTHER | None | None |
| U10CA180868 | NIH | None | None |