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Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane.

Publication ,  Journal Article
Chin, BB; Kronauge, JF; Femia, FJ; Chen, J; Maresca, KP; Hillier, S; Petry, NA; James, OG; Oldan, JD; Armor, T; Stubbs, JB; Stabin, MG; Babich, JW
Published in: J Nucl Med
May 2014

UNLABELLED: A first-in-human phase 1 clinical study was performed on 12 healthy adults with a high-specific-activity carrier-free formulation of (123)I-iobenguane. Clinical data are presented on the behavior of this receptor-targeting imaging agent. METHODS: Whole-body and thoracic planar and SPECT imaging were performed over 48 h for calculation of tissue radiation dosimetry and for evaluation of clinical safety and efficacy. RESULTS: A reference clinical imaging database acquired over time for healthy men and women injected with high-specific-activity (123)I-iobenguane showed organ distribution and whole-body retention similar to those of conventional (123)I-iobenguane. The heart-to-mediastinum ratios for the high-specific-activity formulation were statistically higher than for conventional formulations, and the predicted radiation dosimetry estimations for some organs varied significantly from those based on animal distributions. CONCLUSION: Human normal-organ kinetics, radiation dosimetry, clinical safety, and imaging efficacy provide compelling evidence for the use of high-specific-activity (123)I-iobenguane.

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Published In

J Nucl Med

DOI

EISSN

1535-5667

Publication Date

May 2014

Volume

55

Issue

5

Start / End Page

765 / 771

Location

United States

Related Subject Headings

  • Whole Body Imaging
  • Tomography, Emission-Computed, Single-Photon
  • Tissue Distribution
  • Time Factors
  • Radiopharmaceuticals
  • Radiometry
  • Radiographic Image Interpretation, Computer-Assisted
  • Radiation Dosage
  • Phantoms, Imaging
  • Nuclear Medicine & Medical Imaging
 

Citation

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Chin, B. B., Kronauge, J. F., Femia, F. J., Chen, J., Maresca, K. P., Hillier, S., … Babich, J. W. (2014). Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane. J Nucl Med, 55(5), 765–771. https://doi.org/10.2967/jnumed.113.124057
Chin, Bennett B., James F. Kronauge, Frank J. Femia, Jianqing Chen, Kevin P. Maresca, Shawn Hillier, Neil A. Petry, et al. “Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane.J Nucl Med 55, no. 5 (May 2014): 765–71. https://doi.org/10.2967/jnumed.113.124057.
Chin BB, Kronauge JF, Femia FJ, Chen J, Maresca KP, Hillier S, et al. Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane. J Nucl Med. 2014 May;55(5):765–71.
Chin, Bennett B., et al. “Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane.J Nucl Med, vol. 55, no. 5, May 2014, pp. 765–71. Pubmed, doi:10.2967/jnumed.113.124057.
Chin BB, Kronauge JF, Femia FJ, Chen J, Maresca KP, Hillier S, Petry NA, James OG, Oldan JD, Armor T, Stubbs JB, Stabin MG, Babich JW. Phase-1 clinical trial results of high-specific-activity carrier-free 123I-iobenguane. J Nucl Med. 2014 May;55(5):765–771.

Published In

J Nucl Med

DOI

EISSN

1535-5667

Publication Date

May 2014

Volume

55

Issue

5

Start / End Page

765 / 771

Location

United States

Related Subject Headings

  • Whole Body Imaging
  • Tomography, Emission-Computed, Single-Photon
  • Tissue Distribution
  • Time Factors
  • Radiopharmaceuticals
  • Radiometry
  • Radiographic Image Interpretation, Computer-Assisted
  • Radiation Dosage
  • Phantoms, Imaging
  • Nuclear Medicine & Medical Imaging