← Back to Search

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

Must not have

Any open wound (skin ulcerations or infections) at or near the site of imaging that would preclude MSOT imaging

Any febrile illness that precludes or delays participation preoperatively

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have open wounds near the imaging area.

Select...

I do not have a fever or illness that would delay surgery.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

MSOT Device

2020

N/A

~60

Temperature Measurement

2020

N/A

~60