Inflammatory Bowel DiseasesPhase 2NCT03546868
Diagnostic Validity of [18F]FSPG PET for the Assessment of Disease Activity in Inflammatory Bowel Disease
A Phase 2 study testing [18F]FSPG in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by Asan Foundation at 2 sites in South Korea.
Trial summary
Diagnostic validity of [18F]FSPG for assessing disease activity will be assessed in subjects with inflammatory bowel disease. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Ulcerative Colitis, Crohn Disease
- What is being tested?
- [18F]FSPG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 14 Aug 2018to 11 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Asan Foundation
Seoul, Songpa-gu, 05505
Asan Foundation
Seoul, 05505
About this study
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.
Diagnostic validity of [18F]FSPG for assessing disease activity will be assessed in subjects with inflammatory bowel disease.
Read the 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.
- Being tested
- [18F]FSPG
- Medical subject headings
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FSPGDrug
Also called FSPG
Patients will receive 200 MBq of [18F]FSPG and undergo PET/CT for assessing disease activity in inflammatory bowel disease
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative Colitis | Experimental | Patients with ulcerative colitis undergoing [18F]FSPG PET/CT scan Receives: Drug: [18F]FSPG |
| Crohn's disease | Experimental | Patients with Crohn's disease undergoing [18F]FSPG PET/CT scan Receives: Drug: [18F]FSPG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 60 - 75 min
Secondary outcomes (1)
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
Measured: 60 - 75 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start14 Aug 2018
- Primary completion11 Jan 2019
- Study completion11 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546868
- Sponsor's protocol ID
- FSPG -1701
- Status last verified
- Dec 2020
- First submitted
- 10 May 2018
- Last updated
- 14 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03546868
- Acronym / sponsor ID
- FSPG -1701
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Asan FoundationUniversity, hospital or other
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 11 Jan 2019 (actual)
- Study completion
- 11 Jan 2019 (actual)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diagnostic validity of [18F]FSPG for assessing disease activity will be assessed in subjects with inflammatory bowel disease.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative Colitis | Experimental | Drug: [18F]FSPGPatients with ulcerative colitis undergoing [18F]FSPG PET/CT scan |
| Crohn's disease | Experimental | Drug: [18F]FSPGPatients with Crohn's disease undergoing [18F]FSPG PET/CT scan |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [18F]FSPGAlso: FSPGPatients will receive 200 MBq of [18F]FSPG and undergo PET/CT for assessing disease activity in inflammatory bowel disease | Drug | Crohn's disease, Ulcerative Colitis |
Primary outcome
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
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)
1 secondary outcome
Area under the receiver operating characteristic curve of active disease
Time frame: 60 - 75 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [18F]FSPG in people with Inflammatory Bowel Diseases and Ulcerative Colitis, run by Asan Foundation at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of active disease (time frame: 60 - 75 min). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.