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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.

18F-FDG-PET/CT for detection of pelvic nodal involvement in inguinal node positive penile carcinoma - A prospective diagnostic accuracy study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/041401
Enrollment
60
Registered
2022-03-25
Start date
Unknown
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C609- Malignant neoplasm of penis, unspecified

Interventions

Intervention1: 18 FDG PET/CT: In Penile cancer patients if groin lymph nodes are clinically already involved, then patients are further investigated to look at extent of spread. The usual tests done a

Sponsors

IRB committee CMC Vellore
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Penile squamous cell carcinoma patients with clinically palpable inguinal lymph nodes who are planned for bilateral ilio-inguinal block dissection.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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. Timepoint: At completion of 60 patients as required in the sample size.—

Secondary

MeasureTime frame
NoneTimepoint: none—

Countries

India

Contacts

Public ContactDr sandeep

CMC, Vellore

nirmaltj@gmail.com9894449526

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026