To prove diagnostic accuracy of PET/CT in all cancer penis patients having groin involvement clinically. If we can prove diagnostic accuracy of the pelvic lymph node involvement, then we can avoid pelvic surgery which will be reduce complications associated with surgery.
Not Applicable
- Conditions
- Health Condition 1: C609- Malignant neoplasm of penis, unspecified
- Registration Number
- CTRI/2022/03/041401
- Lead Sponsor
- IRB committee CMC Vellore
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Penile squamous cell carcinoma patients with clinically palpable inguinal lymph nodes who are planned for bilateral ilio-inguinal block dissection.
Exclusion Criteria
1. Any co-existing medical conditions like: Renal Failure, Uncontrolled Diabetes, Active Infections/Granulomatous Diseases.
2. Distant metastases.
3. Any known allergy to FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose).
4. Inability to comply with the study procedures.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To Validate diagnostic accuracy of fluorine-18 fluorodeoxyglucose positron emission tomography computed tomography (18F-FDG PET/ CT), through specificity, sensitivity, positive predictive value and negative predictive value. <br/ ><br>Timepoint: At completion of 60 patients as required in the sample size.
- Secondary Outcome Measures
Name Time Method oneTimepoint: none