Skip to content

68Gallium-FAPI PET/CT imaging in Chronic inflammatory and fibrotic diseases (PARADISE study)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508190-84-01
Acronym
29BRC23.0029
Enrollment
390
Registered
2024-11-20
Start date
2025-03-13
Completion date
Unknown
Last updated
2025-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory disorders

Brief summary

Binding intensity in TEP, measured by the Standardized uptake value (SUV) max.

Detailed description

To meet the first secondary objective: - Measurement of fixation intensity in PET and measurement of pathology-specific reference score (if applicable)., To meet the second secondary objective: - Measurement of fixation intensity in PET and measurement of other pathology-specific assessment scores (if applicable), To meet the third secondary objective: - Measurement of PET fixation intensity and measurement of pathology-specific biomarkers (if applicable), To meet the fourth secondary objective: - Measurement of PET fixation intensity and measurement of pathology-specific functional parameters (if applicable), To meet the fifth secondary objective: - Measurement of PET fixation intensity and assessment of pathology-specific imaging characteristics (if applicable), To meet the sixth secondary objective: - Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of [18F] F-FDG PET/CT fixation intensity at M0, To address the seventh secondary objective: - Evaluation of [68Ga] Ga-FAPI tracer uptake kinetics in PET according to different pathologies and their phenotypic characteristics., To meet cross-cutting secondary objectives: - Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of SF-36 questionnaire score, - Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of global disease assessment.

Interventions

Sponsors

CHU de Brest
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Binding intensity in TEP, measured by the Standardized uptake value (SUV) max.

Secondary

MeasureTime frame
To meet the first secondary objective: - Measurement of fixation intensity in PET and measurement of pathology-specific reference score (if applicable)., To meet the second secondary objective: - Measurement of fixation intensity in PET and measurement of other pathology-specific assessment scores (if applicable), To meet the third secondary objective: - Measurement of PET fixation intensity and measurement of pathology-specific biomarkers (if applicable), To meet the fourth secondary objective: - Measurement of PET fixation intensity and measurement of pathology-specific functional parameters (if applicable), To meet the fifth secondary objective: - Measurement of PET fixation intensity and assessment of pathology-specific imaging characteristics (if applicable), To meet the sixth secondary objective: - Measurement of [68Ga] Ga-FAPI PET/CT fixation intensity and measurement of [18F] F-FDG PET/CT fixation intensity at M0, To address the seventh secondary objective: - Eval

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026