Status:
COMPLETED
Added-value of SPECT/CT in Patients Undergoing LM/SL for Gynecological Cancers
Lead Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Collaborating Sponsors:
University of Western Ontario, Canada
Conditions:
Cervical Cancer
Vulvar Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Nodal staging is a key-step in pre-treatment assessment of gynecological cancers. In recent years, lymphatic mapping and sentinel lymphadenectomy (LM/SL) as a minimally invasive pelvic lymph nodes sta...
Detailed Description
This clinical trial is aimed at assessing the utility of a minimally invasive surgery preoperatively guided by a new nuclear medicine imaging procedure called SPECT/CT. In patients suffering from an e...
Eligibility Criteria
Inclusion
- Patients with histologically proven gynecological cancers
- Patients with FIGO IA2 and IB1 cervical cancers
- Cervical cancer patients will be scheduled for radical hysterectomy and pelvic lymph node dissection
- Patients with FIGO IB and II vulvar cancers and those of patients with FIGO III with clinically negative regional lymph nodes
- Vulvar cancer patients will be scheduled for vulvectomy and inguinal lymph node dissection
- Informed consent signed by the patient, the gynaecologist, and the nuclear medicine physician referees
Exclusion
- Patients with no histological evidence of gynecological cancer
- Patient with regionally advanced disease or metastatic disease
- Patients with clinically and/or radiologically evident regional lymph node metastases
- Patients who are not scheduled for radical surgery and lymph node dissection
- Patients with physical and/or psychological contraindications
- Recent study in Nuclear Medicine with long half-time isotopes (i.e. T ½ \>48h; 111In, 67Ga, 201Tl, 131I ) performed within 1 week preceding the LM/SL
- Pregnant or lactating patients
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00773071
Start Date
April 1 2008
End Date
February 1 2012
Last Update
June 8 2012
Active Locations (1)
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1
375, South Street Hospital - Dpt. of Nuclear Medicine
London, Ontario, Canada, N6A4G5