Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00070317
Status:
TERMINATED
Last Update Posted:
2017-11-06
First Post:
2003-10-03
Brief Title:
Lymph Node Mapping and Sentinel Lymph Node Identification in Patients With Stage IB1 Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
Lymphatic Mapping and Sentinel Node Identification in Patients With Stage1B1 Cervical Carcinoma
Status:
TERMINATED
Status Verified Date:
2015-06
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 clinical trial is studying how well lymph node mapping and sentinel lymph node identification work in finding lymph node metastases in patients with stage IB1 cervical cancer Diagnostic procedures such as lymph node mapping and sentinel lymph node identification performed before and during surgery may improve the ability to detect lymph node metastases in patients who have cervical cancer
Detailed Description:
OBJECTIVES
I Determine the sensitivity of the sentinel lymph node in the determination of lymph node metastases using preoperative or intraoperative lymphatic mapping in patients with stage IB1 cervical cancer
II Determine the false-negative predictive value of the sentinel lymph node in the determination of lymph node metastases in these patients
OUTLINE This is a multicenter study
Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy Intraoperatively patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter
I Determine the sensitivity of the sentinel lymph node in the determination of lymph node metastases using preoperative or intraoperative lymphatic mapping in patients with stage IB1 cervical cancer
II Determine the false-negative predictive value of the sentinel lymph node in the determination of lymph node metastases in these patients
OUTLINE This is a multicenter study
Patients receive radiolabeled technetium Tc 99m sulfur colloid injected around the tumor 6 hours prior to or after induction of anesthesia right before surgery Patients then undergo radical hysterectomy and complete pelvic and low para-aortic lymphadenectomy Intraoperatively patients undergo lymphatic mapping and sentinel lymph node identification using isosulfan blue or methylene blue injected at 4 locations in the cervix and a hand-held gamma counter
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-2012-02559 | REGISTRY | None | None |
| CDR0000331918 | None | None | None |
| GOG-0206 | OTHER | None | None |
| GOG-0206 | OTHER | None | None |