Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-25 @ 9:16 PM
Study NCT ID:
NCT06803056
Status:
RECRUITING
Last Update Posted:
2025-10-07
First Post:
2024-12-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
Sponsor:
Ruth Chimenti
Organization:
Study Overview
Official Title:
QUANTIFY: Quantitative Understanding of Advanced Novel Techniques for Imaging Fasciitis and Yielding Biomarkers
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QUANTIFY
Brief Summary:
This study is to create a test that can accurately find and measure the problem areas in muscle and fascia tissue, also known as myofascial pain. The hypothesis is that a combination of imaging findings will be able to detect when myofascial pain is present. The goal is to improve management of myofascial pain by making better tools to find changes in the muscle and fascia tissues for a more personalized treatment. This project was funded by the HEAL initiative (https://heal.nih.gov/).
Detailed Description:
The objective of the R61 phase is to use novel imaging techniques to develop a diagnostic biosignature to objectively and accurately determine the location and severity of abnormal myofascial tissue. A cross-sectional study design approach with 3 groups: plantar fasciitis (n=50), Achilles tendinopathy (n=25), and pain-free controls (n=25) to test Specific Aim: Develop a diagnostic imaging biosignature of myofascial tissue to differentiate individuals with plantar fasciitis from other foot pain without a myofascial component (Achilles tendinopathy) and from matched pain-free controls.
The goal is to develop a diagnostic imaging biosignature that will be able to distinguish between A-MTrP in individuals with plantar fasciitis compared to healthy tissue control (pain-free controls). The biosignature developed in this R61 phase will be screened for clinical utility and considered of interest for further study if it meets the following milestone criteria: area under the receiver operating characteristic curve (ROC AUC) \>0.7, sensitivity \>60%, and specificity \>60%. The ROC analysis will estimate diagnostic performance by comparing differences in biosignatures between tissue where myofascial pain is present vs. tissue where pain is absent.
The proposed sample size of 50 individuals with plantar fasciitis, 25 individuals with Achilles tendinopathy, and 25 matched controls was chosen to provide a confidence interval halfwidth of 0.10 for an AUC of 0.70, assuming 5 muscle measurements for each participant and an overall A-MTrPs prevalence of 0.36 in individuals with plantar fasciitis. Further assuming the 20 biomarkers to be considered in the R61 phase have AUCs uniformly distributed from 0.5 to 0.8, will have at least 85% power to obtain a biosignature meeting the milestone criteria.
The goal is to develop a diagnostic imaging biosignature that will be able to distinguish between A-MTrP in individuals with plantar fasciitis compared to healthy tissue control (pain-free controls). The biosignature developed in this R61 phase will be screened for clinical utility and considered of interest for further study if it meets the following milestone criteria: area under the receiver operating characteristic curve (ROC AUC) \>0.7, sensitivity \>60%, and specificity \>60%. The ROC analysis will estimate diagnostic performance by comparing differences in biosignatures between tissue where myofascial pain is present vs. tissue where pain is absent.
The proposed sample size of 50 individuals with plantar fasciitis, 25 individuals with Achilles tendinopathy, and 25 matched controls was chosen to provide a confidence interval halfwidth of 0.10 for an AUC of 0.70, assuming 5 muscle measurements for each participant and an overall A-MTrPs prevalence of 0.36 in individuals with plantar fasciitis. Further assuming the 20 biomarkers to be considered in the R61 phase have AUCs uniformly distributed from 0.5 to 0.8, will have at least 85% power to obtain a biosignature meeting the milestone criteria.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R61AT012275 | NIH | None | https://reporter.nih.gov/quic… | View |