Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study

Prostate Cancer Clinical Trial

Official title:

Photoacoustic Imaging (PAI) of the Prostate: A Clinical Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01551576
• Other study ID #: IRB-22701
• Secondary ID: SU-03012012-9209
• Status: Completed
• Start date: February 2014
• Est. completion date: December 16, 2019

Study information

• Verified date: October 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of our study is to image human prostate tissue using a transrectal photoacoustic imaging probe.

Description:

PRIMARY OBJECTIVE(S): The primary objective of this pilot study is to assess PAI-performance in a clinical setting to understand limitations of our current PAI instrumentation and to help improve the next-generation design. SECONDARY OBJECTIVE(S): To do preliminary evaluations of oxygen saturation in lesions based on PAI-measurements in order to distinguish malignant from benign prostatic tissue as a basis for future studies.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Consent signed
• Male >= 18 and <= 80 years of age
• Patients must have an elevated PSA And/ Or Abnormal digital rectal exam Or Other indication for prostate biopsy Or Patients with biopsy proven prostate cancer who are scheduled for prostatectomy.

Exclusion Criteria:

• History of prostatectomy or other surgical history that would preclude transrectal imaging (i.e. abdominal perineal resection), anal stenosis/stricture disease
• Men with anatomic abnormalities or previous surgical history that make transrectal imaging impossible (for example, men with previous abdominal-perineal bowel resections or anal atresia/stenosis)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Device:
• Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe
Hand held transrectal Combined Ultrasound and photoacoustic imaging (PAI) probe. PAI is a non-ionizing imaging technique

Locations

Country	Name	City	State
United States	Stanford University Cancer Institute	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lesion signal intensity on Photoacoustic Imaging (PAI) in relation to different lesion characteristics and the surrounding tissues	measure of the lesion signal intensity on PAI in relation to different lesion characteristics and the surrounding tissues. The average signal intensity (or more specifically the SNR) of the lesions measured in dB) will be tabulated against lesion depth from the transducer, and lesion size, based on ultrasound measurements	36 months
Secondary	Measures of hypoxia in the lesion	total lesion hemoglobin concentration (HbT) at PAI and percentage SO2 (oxygen saturation) in region of interest (ROI) (average and maximum) which will be tested against lesion characteristics based on histology at pathological examination of the biopsy and/or prostatectomy specimen if the patients proceed to have radical prostatectomy performed	36 months