Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel Disease

Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Subjects With Inflammatory Bowel Disease.

Diagnostic validity of [18F]FSPG for assessing disease activity will be assessed in subjects with inflammatory bowel disease.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis
• Intervention / Treatment: Drug: [18F]FSPG

Detailed Description

[18F]FSPG PET/CT imaging will noninvasively assess system xc- of cancer and inflammation. Diagnostic validity of [18F]FSPG for assessing disease activity will be assessed in subjects with inflammatory bowel disease.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 05505
    • Asan Foundation
  • Songpa-gu
    • Seoul, Songpa-gu, Korea, Republic of, 05505
      • Asan Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject is aged between 19 and 79 years and male or female of any race/ethnicity.
• Subject has had ulcerative colitis or Crohn's disease diagnosed by clinical, endoscopic and histologic evidence at least 3 months prior to screening.
• Subject has symptoms suggestive of active disease at the time of enrollment.
• Subject is scheduled to undergo sigmoidoscopy or colonoscopy for ulcerative colitis or Crohn's disease within 7 days prior to or after the planned study with [18F]FSPG administration.

Exclusion Criteria:

• Subject or subject's legally acceptable representative does not provide written informed consent.
• Subject displays clinical signs of ischemic colitis or has an evidence of pathogenic bowel infection.
• Subject is diagnosed as having inflammatory bowel disease unclassified.
• Subject has been treated with sulfasalazine or intravenous corticosteroids within the previous four weeks prior to the planned study with [18F]FSPG administration.
• Dose escalation of the current inflammatory bowel disease drugs or starting a new oral aminosalicylate, corticosteroid, immunomodulator, biologics, antibiotics, probiotics, or topical preparations is scheduled from the study enrollment to the scheduled sigmoidoscopy or colonoscopy, or 24 hours after [18F]FSPG administration . The dose escalation or starting a new antidiarrheal and/or analgesic drug is allowed.
• Female subject is pregnant or nursing. Exclusion of the possibility of pregnancy is made by one of the following: 1) Woman is physiologically post-menopausal (cessation of menses for more than 2 years), 2) woman is surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of childbearing potential, a serum or urine pregnancy test performed within 24 hours immediately prior to administration of [18F]FSPG has to be negative and the women is advised to apply contraceptive measures during her participation in this study.
• Subject has concurrent severe and/or uncontrolled and/or unstable medical disease (e.g. congestive heart failure, acute myocardial infarction, severe pulmonary disease, chronic renal or hepatic disease which could compromise participation in the study) in the judgment of the investigator.
• Subject is a relative of the investigator, student of the investigator or otherwise dependent.
• Subject has received any investigational drugs or devices within four weeks prior to the study enrollment.
• Subject has been previously included in this study.
• Subject has any other condition or personal circumstances that, in the judgment of the investigator, might make collection of complete data difficult or impossible.
• Subject is allergic to hyoscine or any of ingredients of hyoscine butylbromide, or has myasthenia gravis, megacolon, closed angle glaucoma, or obstructive prostatic hypertrophy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ulcerative Colitis; Patients with ulcerative colitis undergoing [18F]FSPG PET/CT scan	Drug: [18F]FSPG; Patients will receive 200 MBq of [18F]FSPG and undergo PET/CT for assessing disease activity in inflammatory bowel disease; Other Names: FSPG
Experimental: Crohn's disease; Patients with Crohn's disease undergoing [18F]FSPG PET/CT scan	Drug: [18F]FSPG; Patients will receive 200 MBq of [18F]FSPG and undergo PET/CT for assessing disease activity in inflammatory bowel disease; Other Names: FSPG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of active disease	Sensitivity and specificity of [18F]FSPG PET/CT for the diagnosis of subjects with endoscopic evidence of active disease	60 - 75 min
Sensitivity and specificity of severe disease (presence of ulceration)	Sensitivity and specificity of [18F]FSPG PET/CT for the diagnosis of subjects with endoscopic evidence of severe disease (presence of ulceration)	60 - 75 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area under the receiver operating characteristic curve of active disease	Area under the receiver operating characteristic curve, sensitivity and specificity of segmental [18F]FSPG PET/CT assessment for detecting bowel segments with endoscopic evidence of active disease	60 - 75 min

Collaborators and Investigators

• Sponsor: Asan Foundation

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2018
• Primary Completion (Actual): January 11, 2019
• Study Completion (Actual): January 11, 2019

Study Registration Dates

• First Submitted: May 10, 2018
• First Submitted That Met QC Criteria: May 23, 2018
• First Posted (Actual): June 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 14, 2020
• Last Update Submitted That Met QC Criteria: December 11, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases
• Other Study ID Numbers: FSPG -1701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No