Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003429
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
1999-11-01
Brief Title:
PET Scans in Diagnosing Primary or Recurrent Cervical Cancer in Patients Who Are Undergoing Surgery
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Pilot Study of 18F-Flourodeoxyglucose Positron Emission Tomography in the Diagnosis of Primary and Recurrent Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2015-12
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:
RATIONALE New imaging procedures such as fludeoxyglucose F 18 PET scan may improve the ability to detect cancer or recurrence of cancer
PURPOSE Clinical trial to study the effectiveness of fludeoxyglucose F 18 PET scan in diagnosing primary or recurrent cervical cancer in patients who are undergoing surgery
PURPOSE Clinical trial to study the effectiveness of fludeoxyglucose F 18 PET scan in diagnosing primary or recurrent cervical cancer in patients who are undergoing surgery
Detailed Description:
OBJECTIVES
Assess the feasibility of using fludeoxyglucose F 18 FDG positron emission tomography PET imaging in patients with primary or recurrent cervical cancer
Investigate the ability of FDG-PET scan imaging to detect lymph node metastases in these patients
Investigate the ability of FDG-PET imaging to identify locally advanced disease in early stage cervical cancers
Compare FDG-PET to CT scan imaging with respect to distinguishing between postradiation pelvic fibrosis and recurrent cervical cancer
Investigate the ability of FDG-PET to identify recurrent cervical cancer
OUTLINE This is a diagnostic study
Patients with primary cervical cancer receive fludeoxyglucose F 18 FDG intravenously followed 45 minutes later with positron emission tomography PET imaging over 60 minutes as well as computed tomography CT scan Both diagnostic imaging techniques are to assess the abdomen and pelvis and must be done within 2 weeks prior to surgery Patients eligible for surgery undergo radical hysterectomy and lymphadenectomy and all specimens are evaluated for correlation with the preoperative diagnostic tests findings
Patients with recurrent cervical cancer obtain FDG-PET scan and CT scan of the thorax abdomen and pelvis prior to surgical exploration for pelvic exenteration All biopsy specimens are evaluated for correlation with diagnostic tests findings
PROJECTED ACCRUAL A total of 30 patients 20 patients with primary cervical cancer and 10 patients with recurrent cervical cancer will be accrued for this study
Assess the feasibility of using fludeoxyglucose F 18 FDG positron emission tomography PET imaging in patients with primary or recurrent cervical cancer
Investigate the ability of FDG-PET scan imaging to detect lymph node metastases in these patients
Investigate the ability of FDG-PET imaging to identify locally advanced disease in early stage cervical cancers
Compare FDG-PET to CT scan imaging with respect to distinguishing between postradiation pelvic fibrosis and recurrent cervical cancer
Investigate the ability of FDG-PET to identify recurrent cervical cancer
OUTLINE This is a diagnostic study
Patients with primary cervical cancer receive fludeoxyglucose F 18 FDG intravenously followed 45 minutes later with positron emission tomography PET imaging over 60 minutes as well as computed tomography CT scan Both diagnostic imaging techniques are to assess the abdomen and pelvis and must be done within 2 weeks prior to surgery Patients eligible for surgery undergo radical hysterectomy and lymphadenectomy and all specimens are evaluated for correlation with the preoperative diagnostic tests findings
Patients with recurrent cervical cancer obtain FDG-PET scan and CT scan of the thorax abdomen and pelvis prior to surgical exploration for pelvic exenteration All biopsy specimens are evaluated for correlation with diagnostic tests findings
PROJECTED ACCRUAL A total of 30 patients 20 patients with primary cervical cancer and 10 patients with recurrent cervical cancer will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G98-1452 | None | None | None |
| MSKCC-98047 | None | None | None |