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Trial record 24 of 243823 for:    Diseases

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

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ClinicalTrials.gov Identifier: NCT03546868
Recruitment Status : Recruiting
First Posted : June 5, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Asan Foundation

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

Condition or disease Intervention/treatment Phase
Inflammatory Bowel Diseases Ulcerative Colitis Crohn Disease Drug: [18F]FSPG Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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.
Actual Study Start Date : August 14, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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 Name: 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 Name: FSPG




Primary Outcome Measures :
  1. Sensitivity and specificity of active disease [ Time Frame: 60 - 75 min ]
    Sensitivity and specificity of [18F]FSPG PET/CT for the diagnosis of subjects with endoscopic evidence of active disease

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


Secondary Outcome Measures :
  1. Area under the receiver operating characteristic curve of active disease [ Time Frame: 60 - 75 min ]
    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



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Ages Eligible for Study:   19 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03546868


Contacts
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Contact: Jae Eun Kim, PM +82-2-3010-4572 kje0216@amc.seoul.kr

Locations
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Korea, Republic of
Asan Foundation Recruiting
Seoul, Songpa-gu, Korea, Republic of, 05505
Contact: Jae Eun Kim    +82-2-3010-4572 ext 4571    kje0216@amc.seoul.kr   
Contact: Sun Young Chae, M.D    +82-2-3010-5448    sychae@amc.seoul.kr   
Asan Foundation Recruiting
Seoul, Korea, Republic of, 05505
Contact: Jae Eun Kim    +82-2-3010-4572 ext 4571    kje0216@amc.seoul.kr   
Contact: Sun Young Chae, M.D    +82-2-3010-5448    sychae@amc.seoul.kr   
Sponsors and Collaborators
Asan Foundation

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Responsible Party: Asan Foundation
ClinicalTrials.gov Identifier: NCT03546868     History of Changes
Other Study ID Numbers: FSPG -1701
First Posted: June 5, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colitis
Colonic Diseases