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J Nucl Med. 2012; 53 (Supplement 1):455
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Molecular Targeting Probes - Radioactive and Nonradioactive

Oncology Probes--Therapy & Monitoring

Synthesis of 213Bi-DOTATOC for peptide receptor alpha-therapy of GEP-NET patients refractory to beta therapy

Alfred Morgenstern1, Frank Bruchertseifer1, Christos Apostolidis1, Frederik Giesel2, Walter Mier2, Uwe Haberkorn2 and Clemens Kratochwil2

1 European Commission, Joint Research Centre, Institute for Transuranium Elements, Karlsruhe, Germany 2 Department of Nuclear Medicine, University Hospital Heidelberg, Heidelberg, Germany

Abstract No. 455

Objectives: We report a method for the synthesis of alpha emitter labeled 213Bi-DOTATOC in clinical levels and give an interim analysis of an ongoing dose escalation study assessing the toxicity and efficacy of i.a. administered 213Bi-DOTATOC in patients with gastroenteropancreatic neuroendocrine tumors (GEP-NET) refractory to previous treatment with 90Y- or 177Lu-DOTATOC.

Methods: 213Bi-DOTATOC was synthesized using a microwave assisted labeling protocol. 17 GEP-NET patients were enrolled. The activity administered in a single treatment cycle was escalated from 1-10 GBq, the cumulative activity was up to 20 GBq 213Bi per patient. Response was assessed with contrast enhanced sonography, MRI, DSA, 68Ga-DOTATOC-PET/CT and tumor markers. Markers for hematologic, kidney and endocrine toxicity were monitored initially, during and after treatment.

Results: The labeling protocol allowed reliable synthesis of 213Bi-DOTATOC at doses up to 1.5 GBq with specific activities up to 240 MBq/nmol and radiochemical purity of 99.7±0.3%. No acute kidney, endocrine or hematologic toxicity higher than grade 0/I were observed after administration of ≤6 GBq per cycle. Moderate hair loss occurred in 3 of 6 patients receiving single doses of 6 to 10 GBq; 1 case of radiation pneumonitis was observed in the patient receiving 10 GBq. While morphologic long term response is still pending, shrinkage of primary tumors as well as liver and bone metastases has already been observed.

Conclusions: This study demonstrates that 213Bi-DOTATOC can be reliably synthesized in clinical settings. The maximum tolerable dose of a single administration of 213Bi-DOTATOC has been determined as 6 GBq. Therapeutic effects have been observed in several patients refractory to treatment with beta emitters. Peptide receptor alpha therapy with 213Bi-DOTATOC is evolving as a new treatment option for GEP-NET patients refractory to standard therapies





This Article
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Right arrow Alert me to new issues of the journal
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Google Scholar
Right arrow Articles by Morgenstern, A.
Right arrow Articles by Kratochwil, C.
PubMed
Right arrow Articles by Morgenstern, A.
Right arrow Articles by Kratochwil, C.