NCT03546868

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 10, 2018

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

August 14, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2019

Completed
Last Updated

December 14, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

May 10, 2018

Last Update Submit

December 11, 2020

Conditions

Inflammatory Bowel DiseasesUlcerative ColitisCrohn Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Area under the receiver operating characteristic curve of active disease

    60 - 75 min

Study Arms (2)

Ulcerative Colitis

EXPERIMENTAL

Patients with ulcerative colitis undergoing \[18F\]FSPG PET/CT scan

Drug: [18F]FSPG

Crohn's disease

EXPERIMENTAL

Patients with Crohn's disease undergoing \[18F\]FSPG PET/CT scan

Drug: [18F]FSPG

Interventions

[18F]FSPGDRUG

Patients will receive 200 MBq of \[18F\]FSPG and undergo PET/CT for assessing disease activity in inflammatory bowel disease

Also known as: FSPG
Crohn's diseaseUlcerative Colitis

Eligibility Criteria

Age19 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Asan Foundation

Seoul, Songpa-gu, 05505, South Korea

Location

Asan Foundation

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Inflammatory Bowel DiseasesColitis, UlcerativeCrohn Disease

Interventions

4-(3-fluoropropyl)glutamic acid

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2018

First Posted

June 6, 2018

Study Start

August 14, 2018

Primary Completion

January 11, 2019

Study Completion

January 11, 2019

Last Updated

December 14, 2020

Record last verified: 2020-12

Locations

KR(2)