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A study to predict the response to Anti-vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy at an early stage on 68Gallium-PSMA-11 PET/CT in patients of metastatic renal cell cancer

Not Applicable
Completed
Conditions
Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis
Registration Number
CTRI/2021/05/033805
Lead Sponsor
Postgraduate Institute of Medical Education and Research
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
27
Inclusion Criteria

1. Adults = 18 years of age

2. Biopsy proven metastatic Renal Cell Cancer

3. Planned for targeted TKI therapy (first and second line).

4. Life expectancy > 6 months.

5. Patient consent to participate in the study.

Exclusion Criteria

1. Pregnant or lactating women.

2. Active malignancy other than renal cell cancer.

3. Tyrosine Kinase Inhibitor Therapy (TKI) within 4 weeks prior to enrolment.

4. Patients not giving consent to participate

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Qualitative and quantitative (SUVmax) response to treatment on 68Ga-PSMA-11 PET/CT according to adapted PERCIST criteriaTimepoint: baseline and 1 month
Secondary Outcome Measures
NameTimeMethod
Correlation with anatomical size change on CT according to RECIST 1.1Timepoint: baseline and 3 months
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