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Molecular Imaging and Biology

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01-06-2016 | Research Article

Convenient Preparation of [⁶⁸Ga]DKFZ-PSMA-11 Using a Robust Single-Vial Kit and Demonstration of Its Clinical Efficacy

Authors: Drishty Satpati, Ajit Shinto, K. K. Kamaleshwaran, Surekha Sane, Sharmila Banerjee

Published in: Molecular Imaging and Biology | Issue 3/2016

Abstract

Purpose

[⁶⁸Ga]DKFZ-PSMA-11 has proved to be an important diagnostic radiotracer for targeting prostate-specific membrane antigen (PSMA) overexpression in both recurrent prostate cancer (PC) and relevant metastatic sites. However, the widespread, routine clinical use of such a potential radiopharmaceutical demands availability of a ready-to-use kit formulation to enable convenient radiopharmaceutical preparation. Herein, we report the development of a freeze-dried kit vial for the formulation of [⁶⁸Ga]DKFZ-PSMA-11 and its clinical use in patients using a “shake-bake-inject” methodology.

Procedures

The freeze-dried kit vial was developed after optimization of ligand content (PSMA-11) and pH conditions. The kit was formulated using ⁶⁸Ga from two different commercially available generators. Positron emission tomography/X-ray computed tomography (PET/CT) images of PC patients were obtained using the kit-formulated radiotracer.

Results

[⁶⁸Ga]DKFZ-PSMA-11 was prepared in >98 % radiochemical yield and purity using the freeze-dried kit vials. Kits were optimized for the preparation of four patient doses. The clinical utility was evaluated in patients with histologically confirmed prostate cancer, and the images were of good quality as well as conforming to tumor marker and clinical expectations.

Conclusion

The development of a simple and ready-to-use freeze-dried DKFZ-PSMA-11 kit for the preparation of Ga-68-based radiotracers constitutes a major step towards the expedition of the widespread and economical screening of PC patients.

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Title: Convenient Preparation of [68Ga]DKFZ-PSMA-11 Using a Robust Single-Vial Kit and Demonstration of Its Clinical Efficacy
Authors: Drishty Satpati
Ajit Shinto
K. K. Kamaleshwaran
Surekha Sane
Sharmila Banerjee
Publication date: 01-06-2016
Publisher: Springer US
Published in: Molecular Imaging and Biology / Issue 3/2016
Print ISSN: 1536-1632
Electronic ISSN: 1860-2002
DOI: https://doi.org/10.1007/s11307-016-0943-z

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Convenient Preparation of [⁶⁸Ga]DKFZ-PSMA-11 Using a Robust Single-Vial Kit and Demonstration of Its Clinical Efficacy

Abstract

Purpose

Procedures

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Procedures

Results

Conclusion

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