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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

Role of 68gallium-PSMA-11 PET/CT in early response prediction to anti-vascular endothelial growth factor receptor tyrosine kinase inhibitor therapy in metastatic renal cell carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/05/033805
Enrollment
20
Registered
2021-05-25
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: C649- Malignant neoplasm of unspecifiedkidney, except renal pelvis

Interventions

Intervention1: 68Gallium-PSMA-11 PET/CT: baseline, 1 month and 3 months Control Intervention1: anatomical size response on CT according to RECIST 1.1: Baseline and 3 months

Sponsors

Postgraduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Qualitative and quantitative (SUVmax) response to treatment on 68Ga-PSMA-11 PET/CT according to adapted PERCIST criteriaTimepoint: baseline and 1 month—

Secondary

MeasureTime frame
Correlation with anatomical size change on CT according to RECIST 1.1Timepoint: baseline and 3 months—

Countries

India

Contacts

Public ContactPiyush Aggarwal

Postgraduate Institute of Medical Education and Research

drharmandeepsingh@gmail.com7087003374

Outcome results

None listed

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