Trials / Terminated
TerminatedNCT06125028
[68Ga]Ga-PentixaFor-PET Imaging for Staging of Marginal Zone Lymphoma
A Pivotal Phase 3 Clinical Trial to Assess the Diagnostic Performance and Safety of [68Ga]Ga-PentixaFor ([68Ga]Ga-PTF), a Positron Emission Tomography (PET) Imaging Agent, Versus [18F]FDG PET/CT Imaging, for Staging of Patients With Confirmed Marginal Zone Lymphoma Exemplary for CXCR4-positive Malignant Lymphomas: a Prospective, International, Multi-center, Comparative, Randomized, Cross-over, Open-label Lymphoma Diagnostic Trial
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Pentixapharm AG · Industry
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
This will be a pivotal prospective prospective, international, multi-center, comparative, randomized, cross-over, open-label lymphoma diagnostic trial to assess the diagnostic performance and safety of the positron emission tomography (PET) imaging agent \[68Ga\]Ga-PTF) , versus \[18F\]FDG PET/CT imaging, for staging of patients with confirmed marginal zone lymphoma exemplary for CXCR4-positive malignant lymphomas.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | [68Ga]Ga-PentixaFor | \[68Ga\]Ga-PTF i.v. injection |
| DRUG | [18F]Fluorodeoxyglucose | \[18F\]FDG i.v. injection. |
Timeline
- Start date
- 2024-05-20
- Primary completion
- 2025-07-18
- Completion
- 2025-07-18
- First posted
- 2023-11-09
- Last updated
- 2025-09-05
Locations
12 sites across 5 countries: Austria, France, Germany, Italy, Spain
Source: ClinicalTrials.gov record NCT06125028. Inclusion in this directory is not an endorsement.