FDG PET CT role in High risk renal cancer and Bladder cancer

Not Applicable

• Conditions: Health Condition 1: C679- Malignant neoplasm of bladder, unspecifiedHealth Condition 2: C688- Malignant neoplasm of overlappingsites of urinary organsHealth Condition 3: C669- Malignant neoplasm of unspecifiedureterHealth Condition 4: O- Medical and Surgical

• Registration Number: CTRI/2022/07/043691
• Lead Sponsor: AIIMS Jodhpur

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. All patients attending the urology OPD of AIIMS, Jodhpur and more than 18 years of age with imaging or biopsy findings suggestive of primary renal malignancy TNM stage T2 and/ or N1 and above.

2. All patients attending the urology OPD of AIIMS, Jodhpur and more than 18 years of age with imaging or biopsy findings suggestive of muscle invasive carcinoma urinary bladder or N1 and above.

3. All patients giving written, informed patient.

4. All patients willing and able to comply with the required procedures of the study in the opinion of the investigator.

Exclusion Criteria

1. Any patient not giving consent for the study.

2. Any patient with poor performance status or life expectancy excluding him/ her from curative surgery or radiotherapy or use of oral/ intravenous therapy.

3. Known case of renal, UTUC bladder malignancy post curative intent.

4. Known case of metastatic malignancy already on treatment for advanced disease.

5. Patient with compromised renal function in whom administration of IV iodinated contrast is contraindicated.

6. Patient with known hypersensitivity to the radiotracer or contrast agent to be used.

7. A history of other known malignancy within the last two years with the exception of melanoma or any other known skin cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the primary outcomes are to assess accuracy , management impact, incremental accuracy of second line imaging i.e PET-CYTimepoint: 4 weeks followed by 8 weeks then follow up on 6 months, 18 months, 30 months, 42 months and 54 months.

Secondary Outcome Measures

Name	Time	Method
secondary outcomes are : ââ?¬Â¢Equivocal studies ââ?¬â?? Any scan in which the distant lesion or none of the lesions in case of multiple lesions has been reported to be equivocal for metastatic nature will be considered an equivocal study. <br/ ><br>ââ?¬Â¢Prognostic value ââ?¬â?? The prognostic value of FDG PET-CT is the ability of a negative PET-CT at baseline to predict the time till recurrence, i.e., development of distant or local recurrence following definitive therapy. Kaplan Meier curves will be plotted for the time until the appearance of distant or locally recurrent disease.Timepoint: 4 weeks followed by 8 weeks then follow up on 6 months, 18 months, 30 months, 42 months and 54 months.