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J Nucl Med. 2008; 49 (Supplement 1):92P
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Radiopharmaceutical Chemistry: Radiopharmacy

Radiopharmacy I

Use of exploratory INDs in evaluation of 18F-labeled PET amyloid plaque imaging agents

Michael Pontecorvo1, Alan Carpenter1, R. Edward Coleman2, Kirk Frey3, Franz Hefti1, Val Lowe4, Mark Mintun5, Raj Manchanda1, Dean Wong6 and Daniel Skovronsky1

1 Avid Radiopharmaceuticals, Philadelphia, Pennsylvania; 2 Duke Univ, Raleigh, North Carolina; 3 Univ Michigan, Ann Arbor, Michigan; 4 Mayo Clinic, Rochester, Minnesota; 5 Washington Univ, St Louis, Missouri; 6 Johns Hopkins Med Inst, Baltimore, Maryland

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Objectives: To use Exploratory INDs (ExpIND) to select an 18F-PET amyloid imaging agent.

Methods: ExpINDs allowing early stage studies are ideal for radiotracers, especially amyloid imaging agents for which there are no appropriate animal models. We employed ExpINDs to study 4 related novel 18F-PET amyloid imaging agents, AV-19, AV-45, AV-138 and AV-144. These ExpINDs contained preclinical data on mechanism of action, secondary pharmacology, biodistribution, pharmacokinetics and dosimetry and extended acute toxicology. Each multicenter clinical trial assessed brain uptake, pharmacokinetics, metabolism, and safety in 15 elderly controls (C) and 15 AD patients. Subjects received an i.v. bolus of 5 or 10 mCi, then dynamic brain PET-imaging. A subset also received whole body scans at early and late timepoints (preliminary dosimetry).

Results: No serious adverse events and no significant changes in vital signs, ECG or labs occurred. Compared to C, AD patients accumulated tracer in cortical areas expected to be high in amyloid. This effect was smaller for AV-19 than for the remaining compounds. Evaluation of AV-19 ended after 8 subjects. Evaluation of the remaining compounds continues with >70 subjects enrolled. The patient numbers in these ExpINDs may be too small to clearly establish differences in amyloid binding (cortical/cerebellum SUVR in AD vs C) among these latter agents, but differences have been noted in kinetics, optimal imaging time and biodistribution/dosimetry.

Conclusions: ExpINDs were useful in comparing 4 related agents with respect to efficacy (amyloid binding), kinetics and dosimetry.

Research Support: Avid Radiopharmaceuticals





This Article
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Right arrow Alert me to new issues of the journal
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Right arrow Articles by Pontecorvo, M.
Right arrow Articles by Skovronsky, D.
PubMed
Right arrow Articles by Pontecorvo, M.
Right arrow Articles by Skovronsky, D.