FAPi-PET imaging of in vivo early fistula healing in perianal Crohn’s disease: PERSIST study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Amsterdam UMC

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06], Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

Trial duration

24 Nov 2023 → ongoing

Decision date (initial)

2023-07-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Helmsley Charitable Trust

External identifiers

EU CT number

2023-505317-25-00

WHO UTN

U1111-1289-5268

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy, Pharmacodynamic, Therapy, Safety

The feasibility of 68Ga-FAPi-46 PET-CT for fibroblast activation pattern visualization and quantification during early healing of perianal Crohn’s fistulas.

Secondary objectives 2

1. - Optimization in quantification methodology and acquisition procedure of 68Ga-FAPi-46 PET-CT
2. - Assessment of 68Ga-FAPi-46 PET-CT to predict therapy response of perianal Crohn’s fistulas with regard to clinical and non-PET imaging findings

Conditions and MedDRA coding

perianal Crohn's fistula

Regulatory references

Plan to share IPD

No

IPD plan description

n/a

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 1. Confirmed diagnosis of CD with previously or currently documented luminal inflammation (endoscopy and histopathology)
2. 2. Complex perianal fistula, defined as either involving the upper two-third of the sphincter complex (i.e., high intersphincteric, high transsphincteric, suprasphincteric or extrasphincteric course of the fistula tract), having multiple external openings, are associated with pain or fluctuation suggesting a perianal abscess or are associated with a rectovaginal fistula or anorectal stricture or active rectal ulcers, with active drainage (fluid loss on gentle compression; perianal fistulas that were previously close but that reopened can be included).
3. 3. Age 16 or older
4. 4. Signed informed consent

Exclusion criteria 1

1. 1. Patients with Ulcerative Colitis or IBD-U 2. Presence of impassible anal stricture 3. Superficial or rectovaginal fistula only 4. Patients with ongoing abdominal or undrained perianal abscesses after repeated examination-under-anesthesia with drainage by incision or seton placement 5. Patients with a seton in situ > 12 months 6. Patients with an ostomy 7. Enteric pathogens (such as Salmonella, Shigella, Yersinia, Campylobacter and C. difficile) detected by stool analysis within 2 weeks prior to enrollment or at screening 8. Active or planned pregnancy or lactation Patients previously exposed to two or more anti-TNFs 9. Previously unacceptable side effects or intolerance to all immunosuppressants (both thiopurines and methotrexate) Treatment with vedolizumab or ustekinumab within 30 days 10. Active or latent tuberculosis (screening according to national guidelines) 11. Cardiac failure in NYHA stage III-IV 12. History of demyelinating disease 13. Recent live vaccination (≤ 4 weeks) 14. Patients with ongoing acute/chronic infection (including but not limited to HIV, hepatitis B and C) with the exception of chronic herpes labialis or cervical HPV 15. Male patients with negative EBV serology 16. Patients who received any investigational drug in the past 30 days or 5 half-lives, whichever is longer 17. Patients with a history of colon cancer or colonic dysplasia, unless sporadic adenoma, which has been removed 18. A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures 19. Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures 20. Patients unable to attend all study visits 21. Participation in a medical intervention trial that interferes with this study in the opinion of the PI 22. Patients with a history of non-compliance with clinical study protocols

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. - Visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline, at follow-up (T1) and the change over both time points

Secondary endpoints 5

1. - The best fitting kinetic model to quantify 68Ga-FAPi-46 pharmacokinetics and tracer uptake.
2. - The most suitable simplified quantitative measurement as a surrogate for the full kinetic model.
3. - The most simplified imaging procedure providing the quantitative measurement correlating to the full kinetic model.
4. - Correlate visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline, at follow-up (week 2 or week 6 or combined) and the change over both time points with clinical and/or radiological response assessments mid- and end-of-treatment (i.e. week 9 and week 26, respectively).
5. - Correlate visual and quantitative 68Ga-FAPi-46 uptake measurements in and around the perianal fistula at baseline with clinical and MRI (and eventual endoscopy and pathology if available) parameters at baseline.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Amsterdam UMC

Sponsor organisation

Amsterdam UMC

Address

Meibergdreef 9

City

Amsterdam

Postcode

1105 AZ

Country

Netherlands

Scientific contact point

Organisation

Amsterdam UMC

Contact name

Lieven Mulders, PhD fellow

Public contact point

Organisation

Amsterdam UMC

Contact name

Lieven Mulders, PhD fellow

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

2 submissions — initial application plus substantial / non-substantial modifications