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

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

NCT ID: NCT06125028

Condition: Marginal Zone Lymphoma

Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell, Marginal Zone
Fluorodeoxyglucose F18

Study type: Interventional

Study phase: Phase 3

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Other

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: [68Ga]Ga-PentixaFor
Description: [68Ga]Ga-PTF i.v. injection
Arm group label: [68Ga]Ga-PTF PET/CT

Other name: [68Ga]Ga-PTF

Intervention type: Drug
Intervention name: [18F]Fluorodeoxyglucose
Description: [18F]FDG i.v. injection.
Arm group label: [18F]FDG PET/CT

Other name: [18F]FDG

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Signed informed consent form (ICF) from the patient. 2. Patients of either gender, aged ≥ 18 years. 3. Patients with a histologically proven diagnosis of MZL according to the World Health Organization 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: - No renal impairment: Estimated glomerular filtration rate (eGFR) or creatinine clearance by the Cockcroft-Gault equation (or equivalent) should be > 30 mL/min/1.73 m2 or > 60 mL/min, respectively. - Total bilirubin ≤ 1.5 × ULN (upper limit of normal) - Serum albumin ≥ 2.5 g/dL - Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN or ≤ 5 × ULN in the presence of liver metastases - International normal ratio (INR) < 1.3 or ≤ institutional ULN. 8. Life expectancy ≥ 12 weeks as estimated by the Investigator. 9. The patient must not have undergone any physical or pharmacological intervention with curative or palliative intent between the time of any of the diagnostic measures and the [68Ga]Ga-PTF PET/CT and [18F]FDG PET/CT scan. Exclusion Criteria: 1. Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PTF and/or [18F]FDG product. 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 or [18F]FDG PET/CT imaging. 4. Patients presenting uncontrolled diabetes (glycemia > 8 mmol/L or 144 mg/dL ) 5. Administration of any anticancer therapy within 1 month prior to study entry. 6. Patients with complete resection of the tumor lesion(s). 7. Administration of another investigational medicinal product within 30 days or within 5 terminal elimination half-lives of a 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" (CTCAE version 5.0) except if tumor-related. 9. Pregnant or breast-feeding women. 10. Concomitant prohibited treatment which may interfere with [68Ga]Ga-PTF PET/CT imaging (e.g., systemic corticosteroids) and/or [18F]FDG PET/CT imaging administered within the last 1 month prior to study start. 11. Judged by the referring physician as not mentally or as not physically fit to understand and comply with protocol-related interventions and procedures (e.g., medically retarded, body weight > 180 kg for PET scanner). 12. Body weight of less than 48 kg.

Gender: All

Minimum age: 18 Years

Maximum age: 99 Years

Healthy volunteers: No

Locations:

Facility:
Name: Clinica Universidad de Navarra

Address:
City: Pamplona
Zip: 31008
Country: Spain

Status: Recruiting

Contact:
Last name: Dr. García Velloso, MD

Start date: June 2024

Completion date: June 15, 2025

Lead sponsor:
Agency: Pentixapharm AG
Agency class: Industry

Collaborator:
Agency: Pivotal S.L.
Agency class: Industry

Source: Pentixapharm AG

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06125028