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Early response assessment to targeted therapy in metastatic clear cell renal cancer using 68Ga-PSMA-11 PET/CT and comparison with CECT: a feasibility study

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Abstract

Purpose

Contrast-enhanced computed tomography (CECT) underestimates the response to targeted therapy in metastatic renal cell cancer (mRCC) using Response Assessment Criteria In Solid Tumors (RECIST) v1.1, creating an unmet need for better imaging biomarkers for early response assessment. This study explores the feasibility of early response assessment to targeted therapy in metastatic clear cell RCC (ccRCC) using 68Ga-PSMA-11 PET/CT.

Methods

After informed consent, adult patients with biopsy-proven metastatic ccRCC planned for targeted therapy were recruited in this prospective observational pilot study from May 2021 to December 2022. 68Ga-PSMA-11 PET/CT was conducted at baseline and one and three months post-treatment. The concordance between PET and CT responses at one and three months was analysed. Follow-up and comparison of progression-free survival (PFS) between responders and non-responders on PET and CT was done.

Results

Twenty-one metastatic ccRCC patients were included in the final analysis. The response assessment on PET and CT was discordant in 15 out of 21 patients (~ 71%) at one month and in nine out of 21 patients (~ 43%) at three months. There was no significant difference between the median PFS of responders vs non-responders on CT at one (14 m vs. 12 m, p = 0.9) and three months (14 m vs. 12 m, p = 0.6). However, a higher difference in median PFS was observed between responders and non-responders on PET at one (PFS 14 m vs. 1 m, p < 0.001) and three months (PFS 14 m vs. 3 m, p = 0.28), respectively.

Conclusion

Early response assessment with 68Ga-PSMA-11 PET/CT is feasible and provides more accurate prognostic information than CECT in metastatic clear cell RCC patients undergoing targeted therapy.

Trial registration number

CTRI/2021/05/033805 (date of registration: 25/05/21)

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Data availability

The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

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Acknowledgements

We thank the Indian Council of Medical Research (ICMR), New Delhi, India, for providing a research grant for the study (ref ID: MD21JUN-0007). We thank Dr Swayamjeet Satapathy, Senior resident, Department of Nuclear Medicine, All India Institute of Medical Sciences, New Delhi, for his kind assistance in the statistical analysis.

Funding

This work was supported by the Indian Council of Medical Research (ICMR), New Delhi, India (research grant ref ID: MD21JUN-0007).

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Authors and Affiliations

Authors

Contributions

All authors contributed to the study's conception and design. PA, HS, CKD and RSM were involved in patient selection, Material preparation, data collection and analysis were performed by PA, HS, RK, UG, AL and PP. The histopathological data was reviewed by NK. The first draft of the manuscript was written by PA and HS and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Harmandeep Singh.

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Conflict of interest

The authors declare that they have no competing interests.

Ethical approval

This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of Post Graduate Institute of Medical Education and Research, Chandigarh (Date 11.05.21)(NK/7242/MD/040).

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Informed consent was obtained from all individual participants included in the study.

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Aggarwal, P., Singh, H., Das, C.K. et al. Early response assessment to targeted therapy in metastatic clear cell renal cancer using 68Ga-PSMA-11 PET/CT and comparison with CECT: a feasibility study. Clin Transl Imaging (2024). https://doi.org/10.1007/s40336-024-00627-2

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