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Journal of Nuclear Medicine

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Meeting ReportMolecular Targeting Probes - Radioactive & Nonradioactive

Kinetics and dosimetry of 124I-PGN650, a PET tracer for phosphatidylserine exposure in solid tumors.

Richard Laforest, Farrokh Dehdashti, Yongjian Liu, Jennifer Frye, Sarah Frye, Joseph Shan, Bruce Freimark and Barry Siegel
Journal of Nuclear Medicine May 2015, 56 (supplement 3) 1033;
Richard Laforest
1Radiology, Washington University Medical School, St.Louis, MO
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Farrokh Dehdashti
1Radiology, Washington University Medical School, St.Louis, MO
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Yongjian Liu
1Radiology, Washington University Medical School, St.Louis, MO
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Jennifer Frye
1Radiology, Washington University Medical School, St.Louis, MO
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Sarah Frye
1Radiology, Washington University Medical School, St.Louis, MO
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Joseph Shan
2Peregrine Inc., Tustin, CA
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Bruce Freimark
2Peregrine Inc., Tustin, CA
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Barry Siegel
1Radiology, Washington University Medical School, St.Louis, MO
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Abstract

1033

Objectives PGN650 is an F(ab’)2 antibody fragment that targets phosphatidylserine (PS), which becomes exposed in the tumor microenvironment. PGN650 was labeled with 124I for use with PET as an in vivo biomarker of PS exposure. In this phase 0 study, we evaluated its pharmacokinetics, radiation dosimetry and tumor uptake in a cohort of human patients.

Methods Eight patients with known advanced solid tumors (4 gastrointestinal cancer, 1 Ewing sarcoma, 1 melanoma, 2 lung cancer) received ~140 MBq of 124I-PGN650 and underwent PET/CT at ~1 h, ~4 h and either 24 h or 48 h. Radiation dosimetry estimates were obtained from integration of the organ time-activity data and OLINDA for the adult male model. Radiation dosimetry was performed for individual patient and by combining data from all patients. In order to assess the safety of 124I-PGN650, all patients underwent vital sign measurement, clinical laboratory testing, and ECG testing before, during and after completion of imaging. In addition, the patients were monitored for any side effect related to the drug for 7 d after injection. Tumor uptake was assessed qualitatively.

Results Activity was retained predominantly in the liver, spleen and blood; blood clearance was relatively slow (half-life of 46 h). Individual patient dosimetry indicated a dose of 1.35 mGy/MBq to the heart, kidneys and liver for an effective dose of 0.5 mSv/MBq. A bias was observed for patients imaged up to 24 h versus those imaged up to 48 h due to the clearance assumptions. Cumulative dosimetry indicated dose to kidneys, heart and liver of 0.81 mGy/MBq and an effective dose of 0.34 mSv/MBq. Increased tumor uptake was noted in 6 patients, and was best seen at 24 to 48 h. There were no adverse effects in any of the 8 patients, nor were there significant changes in vital signs, laboratory studies or ECGs.

Conclusions 124I-PGN650 is safe and results in acceptable dosimetry and needs further optimization as an imaging agent based on the level of increased tumor uptake on PET/CT.

Research Support This work was performed with funds provided by Peregrine Pharmaceuticals Inc.

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Journal of Nuclear Medicine
Vol. 56, Issue supplement 3
May 1, 2015
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Kinetics and dosimetry of 124I-PGN650, a PET tracer for phosphatidylserine exposure in solid tumors.
Richard Laforest, Farrokh Dehdashti, Yongjian Liu, Jennifer Frye, Sarah Frye, Joseph Shan, Bruce Freimark, Barry Siegel
Journal of Nuclear Medicine May 2015, 56 (supplement 3) 1033;

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Kinetics and dosimetry of 124I-PGN650, a PET tracer for phosphatidylserine exposure in solid tumors.
Richard Laforest, Farrokh Dehdashti, Yongjian Liu, Jennifer Frye, Sarah Frye, Joseph Shan, Bruce Freimark, Barry Siegel
Journal of Nuclear Medicine May 2015, 56 (supplement 3) 1033;
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