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

NCT06125028 | Terminated Phase 3 DMC

• 1 other identifier: PTF301
• Study Type: interventional
• Target: 8
• Locations: 5 countries
• Sites: 12

Brief 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

Marginal Zone Lymphoma

Outcome Measures

Primary Outcomes (2)

• Sensitivity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection

  Through study completion, an average of 6 months

• Specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection

  Through study completion, an average of 6 months

Secondary Outcomes (32)

• Proportion of patients with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians

  Through study completion, an average of 6 months

• Proportion of patients with a change in intended patient management due to additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) as assessed by questionnaires completed by the referring physicians

  Through study completion, an average of 6 months

• Proportion of patients with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by an Independent Committee

  Through study completion, an average of 6 months

• Inter-observer agreement of local and central assessment in terms of staging

  Through study completion, an average of 6 months

• Proportion of patients with nodal MZL with additional or less lesions detected by each PET/CT imaging agent ([68Ga]Ga-PTF and [18F]FDG) compared to pre-PET conventional staging as assessed by questionnaires completed by the referring physicians

  Through study completion, an average of 6 months

Other Outcomes (11)

• Sensitivity of [68Ga]Ga-PTF PET/CT imaging in detecting CXCR4 overexpressing tissue confirmed by a CXCR4 SoT (CXCR4 IHC)

  Through study completion, an average of 6 months

• Specificity of [68Ga]Ga-PTF PET/CT imaging in detecting CXCR4 overexpressing tissue

  Through study completion, an average of 6 months

• Receiver-operating-characteristic (ROC) curve analysis

  Through study completion, an average of 6 months

Study Arms (2)

[68Ga]Ga-PTF PET/CT

EXPERIMENTAL

150 (+/-50) MBq \[68Ga\]Ga-PTF will be administered intravenously and PET/CT will be performed

Drug: [68Ga]Ga-PentixaFor

[18F]FDG PET/CT

ACTIVE COMPARATOR

\[18F\]FDG will be administered once intravenously according to the SMPC and PET/CT will be performed

Drug: [18F]Fluorodeoxyglucose

Interventions

[68Ga]Ga-PentixaFor DRUG

\[68Ga\]Ga-PTF i.v. injection

Also known as: [68Ga]Ga-PTF

[68Ga]Ga-PTF PET/CT

[18F]Fluorodeoxyglucose DRUG

\[18F\]FDG i.v. injection.

Also known as: [18F]FDG

[18F]FDG PET/CT

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients must meet all of the following criteria:
• Signed informed consent from the patient.
• Patients of either gender, aged ≥ 18 years.
• 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).
• Treatment-naïve.
• 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.
• 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.
• Acceptable organ function, as evidenced by the following laboratory data:
• 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
• 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 normalized ratio (INR) \< 1.3 or ≤ institutional ULN.
• Life expectancy ≥ 12 weeks as estimated by the Investigator.
• 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.

You may not qualify if:

• Patients will be excluded if one or more of the following criteria are met:
• Known hypersensitivity to any active pharmaceutical agent or constituent of the \[68Ga\]Ga-PTF and/or \[18F\]FDG investigational products.
• Inability to lie still for the entire imaging time.
• 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.
• Patients with plasma glucose levels higher than 11 mmol/L or 200 mg/dL prior to \[18F\]FDG administration.
• Administration of any anti-cancer therapy within 1 month prior to study entry.
• Patients with complete resection of all tumor lesion(s).
• 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.
• 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.
• Pregnant or breast-feeding women.
• Concomitant prohibited treatment which may interfere with \[68Ga\]Ga-PTF PET/CT imaging (systemic corticosteroids) administered within the last 1 month prior to study start.
• Colony-stimulating factor (CSF) therapy within 5 days prior to \[18F\]FDG PET/CT examination.
• Any recent myocardial infarction, stroke, or osteomyelitis within two months prior screening.
• \[18F\]FDG PET/CT imaging or \[68Ga\]Ga-PTF PET imaging performed prior to study entry.
• 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).

Sponsors & Collaborators

• Pentixapharm AG: lead
• Pivotal S.L.: collaborator

Study Sites (12)

Medizinische Universität Innsbruck

Innsbruck, 6020, Austria

Location

CHU de Bordeaux

Bordeaux, 33600, France

Location

CHU La Timone

Marseille, 13005, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Hôpital Cochin

Paris, 75014, France

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location

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

Meldola, 47014, Italy

Location

Ospedale San Raffaele S.r.l.

Milan, 20132, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, 00168, Italy

Location

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

MeSH Terms

Conditions

Lymphoma, B-Cell, Marginal Zone

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Andreas Buck, Prof. Dr.

  University Hospital Würzburg, Department of Nuclear Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2023
• First Posted: November 9, 2023
• Study Start: May 20, 2024
• Primary Completion: July 18, 2025
• Study Completion: July 18, 2025
• Last Updated: April 28, 2026

Record last verified: 2025-08

Locations

ES (1); IT (4); AU (1); DE (2); FR (4)