Thermography in Surveillance of Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— Thermo  

Official title:

Prototype Study on Association Between Clinical, Laboratory and Thermographic Findings in Patients With Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149043
• Other study ID #: THERMO-01
• Status: Completed
• Start date: January 2015
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: University Hospital Dubrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Ulcerative colitis represents a chronic condition occurring in relapsing and remitting fashion with uncertain outcome and requires lifelong treatment with considerable side effects. Diagnostic methods currently in use, clinical (endoscopy), imaging (CT, MR) or laboratory (C - reactive protein, fecal calprotectin) give an insight into disease activity but are possibly associated with significant discomfort for the patient and / or increased risk of irradiation and potential allergic reactions on contrast agents. For that reason there is a need for a noninvasive, biologically inert method for evaluation of disease activity in inflammatory bowel disease (IBD). Thermography possesses most of these characteristics. The aim of this study is to find potential link between pathological thermographic signs and endoscopic findings, serum C reactive protein (CRP) and calprotectin in the stool of patients with active and extensive ulcerative colitis.

Description:

Hypothesis: Documenting pathological thermographic signs in patients with extensive ulcerative colitis investigators will demonstrate pathological thermography criteria that correlate with standard inflammatory markers such as Mayo endoscopic subscore (ESS), CRP and calprotectin in patients with ulcerative colitis.

Aims: The aim of this study is to record abdominal thermographic images of patients with active ulcerative colitis (UC), to create interpretational thermographic criteria for these images and to compare them to abdominal infrared (IR) images of healthy volunteers. Furthermore, investigators intend to correlate these criteria with standard markers of inflammation such as CRP and calprotectin in patients with UC at the beginning of treatment and at the end.

Materials and methods: For the purpose of this work, 36 patients with extensive UC and 30 healthy individuals will be put throe thermographic imagining, have their stool tested for calprotectin and their blood for CRP. In addition, patients with UC will receive colonoscopy evaluations.

Expected scientific contribution: The results of this paper would give an additional contribution to existing tools for pursuing ulcerative colitis activity thus demonstrating the potential of thermography as a complementary method to standard methods in assessing disease activity. Establishing diagnostic criteria for this method would be a good addition to present clinical practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: June 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Endoscopic diagnosis of active extensive ulcerative colitis

• Stool Calprotectin > 150 mcg/g

• CRP > 5 mg/L

• Signed informed consent form

Exclusion Criteria:

• Inability to preform total colonoscopy

• Marked abdominal comorbidities

• Prior abdominal surgery

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Device:
• Thermography
Thermographic imaging of the patient's abdomen surface

Procedure:
• Colonoscopy
Endoscopic examination of the colon

Locations

Country	Name	City	State
Croatia	University Hospital Dubrava	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Dubrava

Country where clinical trial is conducted

Croatia, 

References & Publications (3)

Banic M, et al. Thermography in patients with inflammatory bowel disease and colorectal cancer: evidence and review of the method. Periodicum biologorum 113(4): 439-444, 2011.

Banic, Marko, et al.

Božin, Tonci, et al.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in abdominal surface temperatures in ulcerative colitis patients at 6 months	Patients will be treated with mesalamin, corticosteroids or biologic therapy according to disease status during 6 months. Abdominal temperatures (maximal, minimum and average temperatures measured in Celsius) recorded by a thermographic camera will be acquired at enrollment and after 6 months of therapy.	Six months
Secondary	Correlation of abdominal surface temperatures between ulcerative colitis patients and healthy volunteers.	Comparison of abdominal surface temperatures (maximum, minimum and average) expressed in Celsius between patients with active ulcerative colitis and healthy controls and also between ulcerative colitis patients in remission and healthy controls.	Baseline and after 6 months
Secondary	Correlation of abdominal surface temperature values with clinical markers of inflammation in ulcerative colitis.	Maximal, minimal and average abdominal surface temperatures expressed in Celsius will be correlated to the Disease Activity Index (Mayo score). The Index assesses stool frequency (0-3 points, according to severity) rectal bleeding (0-3 points, according to severity), mucosal appearance at endoscopy (0-3 points, according to severity) and physician rating of disease activity (0-3 points, according to severity). All of the points make up a total sum to produce a score ranging from 0 to 12 points (no activity, to most severe activity). All correlations will be performed before and after 6 months of therapy.	Baseline and after 6 months
Secondary	Correlation of abdominal surface temperature values with fecal markers of inflammation in ulcerative colitis.	Maximal, minimal and average abdominal surface temperatures expressed in Celsius will be correlated to fecal calprotectin (µg/g) levels. All correlations will be performed before and after 6 months of therapy.	Baseline and after 6 months
Secondary	Correlation of abdominal surface temperature values with serum markers of inflammation in ulcerative colitis.	Maximal, minimal and average abdominal surface temperatures expressed in Celsius will be correlated to serum C - reactive protein (mg/L) levels. All correlations will be performed before and after 6 months of therapy.	Baseline and after 6 months
Secondary	Correlation of abdominal surface temperature values with endoscopic markers of inflammation in ulcerative colitis.	Maximal, minimal and average abdominal surface temperatures expressed in Celsius will be correlated to endoscopic parameters expressed as Mayo endoscopic subscore on a scale 0 - 3. [0 - normal or inactive disease; 1 - mild disease (erythema, decreased vascular pattern, mild friability); 2 - moderate disease (marked erythema, absent vascular pattern, friability, erosions); 3 - severe disease (spontaneous bleeding, ulceration)].; All correlations will be performed before and after 6 months of therapy.	Baseline and after 6 months

External Links

•   University Hospital Dubrava
•   University of Zagreb
•   University of Zagreb School of Medicine