Saturday, December 27, 2025 12/27/2025

DDT-BMQ-000146 Assessing clinically meaningful change in PSC as determined by quantitative MRCP (MRCP+) measured number of strictures

Award Number: U01FD008425
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/01/2024
PERIOD OF PERFORMANCE END DATE: 08/31/2026

Group Awards By:

View Award Description

DDT-BMQ-000146 Assessing clinically meaningful change in PSC as determined by quantitative MRCP (MRCP+) measured number of strictures - Abstract MRCP+ metrics are quantitative markers of the biliary tree which can be used to inform biliary tree health. These markers have shown promise as dynamic biomarkers which can be used to support disease monitoring and, by extension, support the assessment of the effects of pharmacotherapies. In this project, Perspectum Inc. seeks to complete the necessary evidence to qualify the MRCP+ metric number of strictures as a monitoring Drug Development Tool for PSC. It is envisioned that this MRCP+ metric will be used in conjunction with clinical assessments, to identify patients who are more likely to meet endpoints (including biochemical and imaging endpoints) in clinical trials signifying appropriate response to treatments. With the funding from this Drug Development Tools Research Grant, and leveraging the close collaboration with the FDA, we will perform a retrospective multi-center longitudinal observational study in 150 participants. Primary objective: 1. To collect and analyze MRCP data to generate 3D models and associated MRCP+ metrics which will be used to determine the change in the MRCP+ metric ‘number of strictures’ in relation to disease progression. Secondary Objectives: 1. To collect clinical data which can be used to determine the prognostic utility of change in the MRCP+ metric ‘number of strictures’ for predicting clinical outcomes (including cholangitis, requirement for ERCP, cirrhosis, hepatic decompensation, hepatobiliary malignancies, liver transplant or death). 2. To collect clinical data which can be used to determine whether change in predicts incidence free transplant free survival. The study will be performed in collaboration with members of the CALiD registry who will include a representative sample of their patient population. Patients must have at least two time points of interim duration of 6 months or more with associated clinical data.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	PERSPECTUM, INC	400 OYSTER POINT BLVD	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Food and Drug Administration Research	000	1	9/17/2025	NEW	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $245,356 )
2024	2024	PERSPECTUM, INC	400 OYSTER POINT BLVD	SOUTH SAN FRANCISCO	CA	94080	SAN MATEO	USA	Food and Drug Administration Research	000	1	9/2/2024	NEW	$245,356
														Subtotal = $245,356

Grand Total All Awards = $245,356

Top

All Categories

About

Search

Reports

Data Submission

Award Information

DDT-BMQ-000146 Assessing clinically meaningful change in PSC as determined by quantitative MRCP (MRCP+) measured number of strictures

Award Number: U01FD008425

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/01/2024

PERIOD OF PERFORMANCE END DATE: 08/31/2026

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer