Quantitative measurements of medical images for pharmaceutical clinical trials: comparison between on-site and off-site assessments.

Quantitative measurements of medical images for pharmaceutical clinical trials: comparison between on-site and off-site assessments. Research Abstract Details 

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Quantitative measurements of medical images for pharmaceutical clinical trials: comparison between on-site and off-site assessments. Abstract Text:

D Sahani,S Saini,G A Fatuga,E F Halpern,M E Lanser,J B Zimmerman,A J Fischman,

OBJECTIVE: In pharmaceutical clinical trials, quantitative measurements on medical images are often conducted to confirm drug efficacy. This study aims to compare the quantitative image analysis performance of an off-site core laboratory with the performance of investigators from multiple clinical sites. MATERIALS AND METHODS: In a phase I clinical trial, 25 healthy subjects underwent dynamic brain single-photon emission computed tomography (SPECT) scintigraphy with 123I-Altropane, a cocaine analogue with high affinity and selectivity for dopamine transporter sites in the striatum. In 20 patients examined on-site and off-site, a total of 80 measurements were made to calculate the drug's binding potential. A trained technologist off-site at a central core laboratory and on-site investigators at different clinical sites performed the image analysis. These results were compared with measurements made by a subspecialty radiologist whose assessments were the reference standard. Statistical analysis was performed using multiple regression analysis. RESULTS: Measurements from the central core laboratory (off-site) highly correlated (r = 0.95) with measurements of the reference standard. Measurements from the clinical sites (on-site) grouped together had lower correlation (r = 0.84) with the reference standard. This difference was statistically significant (p < 0.05). CONCLUSION: Training and experience in the specific type of image analysis are critical in obtaining consistent data. Quantitative analysis by dedicated personnel at a core laboratory provides highly reproducible results. The findings support off-site assessment of medical images in pharmaceutical clinical trials.

Quantitative measurements of medical images for pharmaceutical clinical trials: comparison between on-site and off-site assessments. Publishing Authors By Initials

D Sahani,S Saini,GA Fatuga,EF Halpern,ME Lanser,JB Zimmerman,AJ Fischman,

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Quantitative measurements of medical images for pharmaceutical clinical trials: comparison between on-site and off-site assessments. Journal Published:

PUBLICATION TYPE: Research Support, Non-U.S. Gov

Journal: AJR. American journal of roentgenology

VOLUME: 174

Page Numbers: 1159-62

Journal Abbreviation:

ISSN: 0361-803X

DAY: 15

MONTH: Apr

YEAR: 2000

Quantitative measurements of medical images for pharmaceutical clinical trials: comparison between on-site and off-site assessments. Information

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LANGUAGE: eng

NlmUniqueID: 7708173

Quantitative measurements of medical images for pharmaceutical clinical trials: comparison between on-site and off-site assessments. Keywords Mesh Terms:

KEYWORDS: Tomography, Emission-Computed, Single-Ph

MESH TERMS: statistics & numerical data

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Grant and Affiliation Information for Quantitative measurements of medical images for pharmaceutical clinical trials: comparison between on-site and off-site assessments.

AFFILIATION: Department of Radiology, Harvard Medical School and Massachusetts General Hospital, Boston 02114, USA.

Country: UNITED STATES

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MEDLINETA: AJR Am J Roentgenol

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