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MSOT Imaging for Inflammation (SCC-O-FLAME Trial)

N/A

Recruiting

Led By Lacey McNally, PhD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients ≥ 18 yrs of age

Patients documented clinical/pathologic 1) acute or chronic colon or skin GVHD, 2) Crohn's disease, or 3) colitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

SCC-O-FLAME Trial Summary

This trial will test a new imaging machine to see if it can detect inflammation in patients with chronic graft versus host disease, Crohn's disease, or colitis.

Who is the study for?

Adults with chronic skin or GI tract graft-versus-host disease, Crohn's disease, or colitis can join. They must have a minimum hemoglobin level of 7.0 mg/dL and be willing to follow the study rules for its duration. Pregnant or breastfeeding individuals, those with tattoos over the inflammation site, febrile illnesses, or open wounds near the imaging area cannot participate.Check my eligibility

What is being tested?

The trial is testing an experimental imaging tool called multispectral optoacoustic tomography (MSOT) to see if it can safely detect inflammation in patients with certain inflammatory conditions like graft-versus-host disease and Crohn's disease.See study design

What are the potential side effects?

Since MSOT is a non-invasive imaging technique similar to getting an ultrasound or MRI scan, there are minimal expected side effects; however specific risks related to this new technology will be monitored.

SCC-O-FLAME Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with GVHD, Crohn's disease, or colitis.

SCC-O-FLAME Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events due to MSOT imaging 4 weeks after treatment.

Adverse Events due to MSOT imaging post enrollment.

Measurement of skin temperature after first MSOT image post enrollment.

+3 more

Secondary outcome measures

Comparison of Collagen deposition values from MSOT images to Crohn's grade/response in Clinical Pathology Reports

Comparison of Collagen deposition values from MSOT images to GVHD grade/response in Clinical Pathology Reports

Comparison of Collagen deposition values from MSOT images to colitis grade/response in Clinical Pathology Reports

+7 more

SCC-O-FLAME Trial Design

1Treatment groups

Experimental Treatment

Group I: Imaging of Inflammatory regionExperimental Treatment2 Interventions

Inflammatory regions of patients scheduled for standard of care clinical visits will be imaged using the MSOT device before and after 4 weeks of treatment. The temperature of their skin prior to and after MSOT imaging will also be measured.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Temperature Measurement

2020

N/A

~60

MSOT Device

2020

N/A

~60

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,823 Total Patients Enrolled

Lacey McNally, PhDPrincipal InvestigatorUniversity of Oklahoma

1 Previous Clinical Trials

54 Total Patients Enrolled

Media Library

MSOT Device Clinical Trial Eligibility Overview. Trial Name: NCT05333978 — N/A

Graft-versus-Host Disease Research Study Groups: Imaging of Inflammatory region

Graft-versus-Host Disease Clinical Trial 2023: MSOT Device Highlights & Side Effects. Trial Name: NCT05333978 — N/A

MSOT Device 2023 Treatment Timeline for Medical Study. Trial Name: NCT05333978 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum capacity of enrollees for this trial?

"Affirmative. Clinicaltrials.gov has provided evidence that this clinical study is actively searching for individuals to participate in the research, which was first posted on May 31st 2022 and most recently updated on June 28th 2022. A total of 100 participants are needed from a single medical site."

Answered by AI

Is recruitment still open for the aforementioned trial?

"As indicated by the information on clinicaltrials.gov, this experiment is actively seeking participants. The original post was published on May 31st 2022 and it has been recently revised as of June 28th 2022."

Answered by AI

To what extent are researchers hoping this experiment will be efficacious?

"The primary analysis of this trial is to assess any Occurrences of Adverse Events due to MSOT imaging 4 weeks after treatment. Secondary outcomes include a Comparison between oxy- and deoxy-hemoglobin values from the MSOT images against prognostic criteria gathered during the study for GVHD patients 4 weeks after treatment, an Assessment into how Clinical Pathology Reports correlate with Clinical Grading of Graft Versus Host Disease in relation to MSOT images, and an Exploration of whether Collagen deposition values obtained via MSOT imaging match up with Crohn's grade/response detailed on Clinical Pathology Reports."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optoacoustic Detection of Inflammation Using MSOT Device

2022. "Optoacoustic Detection of Inflammation Using MSOT Device". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05333978.

All > Graft Vs Host Disease > Colitis