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[68Ga]Ga-PentixaFor-PET Imaging for Staging of Marginal Zone Lymphoma | Clinical Trials | Clareo Health

TERMINATEDPHASE3

[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

NCT06125028•Pentixapharm AG

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•All patients must meet all of the following criteria:
•1. Signed informed consent from the patient.
•2. Patients of either gender, aged ≥ 18 years.
•3. Patients with a histologically proven diagnosis of marginal zone lymphoma (MZL) according to the World Health Organization (WHO) classification of lymphoid neoplasms. Patients must have a biopsy-proven nodal, extranodal, or splenic MZL (at the time of enrolment, the CXCR4 expression status will be unknown).
•4. Treatment-naïve.
•5. Negative pregnancy test in women capable of child-bearing and their agreement to use highly effective contraception for 1 month after the last dose of \[68Ga\]Ga-PTF and \[18F\]FDG.
•6. For male patients whose partner is of child-bearing potential: The patient is willing to ensure that he and his partner use effective contraception for 1 month after the last dose of \[68Ga\]Ga-PTF and \[18F\]FDG.
•7. Acceptable organ function, as evidenced by the following laboratory data:
•1. No renal impairment: Estimated glomerular filtration rate (eGFR) \> 30 mL/min/1.73 m2or creatinine clearance \> 60 mL/min by the Cockcroft-Gault equation or equivalent
•2. Total bilirubin ≤ 1.5 × ULN (upper limit of normal)
+5 more criteria

Exclusion Criteria

•Patients will be excluded if one or more of the following criteria are met:
•1. Known hypersensitivity to any active pharmaceutical agent or constituent of the \[68Ga\]Ga-PTF and/or \[18F\]FDG investigational products.
•2. Inability to lie still for the entire imaging time.
•3. Any severe acute or active chronic infection, as judged by the Investigator, at the time of screening or within two months prior to screening that may interfere with the diagnostic properties of \[68Ga\]Ga-PTF PET/CT and/or \[18F\]FDG PET/CT imaging.
•4. Patients with plasma glucose levels higher than 11 mmol/L or 200 mg/dL prior to \[18F\]FDG administration.
•5. Administration of any anti-cancer therapy within 1 month prior to study entry.
•6. Patients with complete resection of all tumor lesion(s).
•7. Administration of another investigational medicinal product within 30 days or within 5 terminal elimination half-lives of previous investigational medicinal product, whichever is longer, prior to study entry.
•8. Current greater than grade 2 toxicity from any reason, per US-NCI "Common Terminology Criteria for Adverse Events v5.0" (NCI CTCAE 2017) except if tumor-related.
•9. Pregnant or breast-feeding women.
+7 more criteria

Locations (12)

Medizinische Universität Innsbruck

Innsbruck, Austria

CHU de Bordeaux

Bordeaux, France

CHU La Timone

Marseille, France

CHU de Nantes

Nantes, France

Hôpital Cochin

Paris, France

Universitätsklinikum Essen

Essen, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Italy

L'IRCCS Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l

Meldola, Italy

Ospedale San Raffaele S.r.l.

Milan, Italy

Key Dates

Start Date

May 20, 2024

Primary Completion Date

July 18, 2025

Completion Date

July 18, 2025

Last Updated

September 5, 2025

Enrollment

ACTUAL participants

Conditions

Marginal Zone Lymphoma

Interventions

[68Ga]Ga-PentixaFor

DRUG

[18F]Fluorodeoxyglucose

DRUG

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

NCT05006716

B-cell MalignancyMarginal Zone Lymphoma+7 more

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RECRUITINGPHASE1

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

NCT06026319

Non-hodgkin LymphomaRelapsed Non-Hodgkin Lymphoma+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

[68Ga]Ga-PentixaFor-PET Imaging for Staging of Marginal Zone Lymphoma

Inclusion Criteria

Exclusion Criteria

A Dose-Escalation and Expansion Study of BGB-16673 in Participants With B-Cell Malignancies

CD79b-19 CAR T Cells in Non-Hodgkin Lymphoma

Orelabrutinib Combined With Rituximab ± Lenalidomide in Response-Adapted Stratified Therapy for Untreated MZL

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma

Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms