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

Phase 3TerminatedNCT06125028

Pentixapharm AG8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Marginal Zone Lymphoma

Interventions

[68Ga]Ga-PentixaForDRUG

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

[18F]FluorodeoxyglucoseDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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) 3. Serum albumin ≥ 2.5 g/dL. 4. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × ULN or ≤ 5 × ULN in the presence of liver metastases 5. International normalized 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: 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. 10. 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. 11. Colony-stimulating factor (CSF) therapy within 5 days prior to \[18F\]FDG PET/CT examination. 12. Any recent myocardial infarction, stroke, or osteomyelitis within two months prior screening. 13. \[18F\]FDG PET/CT imaging or \[68Ga\]Ga-PTF PET imaging performed prior to study entry. 14. 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). 15. Body weight of less than 48 kg. 16. Any other concurrently active neoplasia, or other disease who could jeopardize study safety or data.

Locations (12)

Medizinische Universität Innsbruck

Innsbruck, Austria

CHU de Bordeaux

Bordeaux, France

CHU La Timone

Marseille, France

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Through study completion, an average of 6 months

Secondary Outcomes

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

Time frame: 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

Time frame: Through study completion, an average of 6 months

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

Time frame: 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

Time frame: Through study completion, an average of 6 months

Data from ClinicalTrials.gov

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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

...and 2 more locations

Proportion of patients with extranodal 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

Time frame: Through study completion, an average of 6 months

Proportion of patients with splenic 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

Time frame: Through study completion, an average of 6 months

Proportion of patients with nodal MZL 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

Time frame: Through study completion, an average of 6 months

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

Time frame: Through study completion, an average of 6 months

Proportion of patients with splenic MZL 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

Time frame: Through study completion, an average of 6 months

Diagnostic performance, consisting of sensitivity and specificity, of each PET/CT imaging agent in tumor detection on a region-basis (eyes, ears, nose, throat, liver, spleen, gastrointestinal tract, bone marrow) confirmed by SoT or surrogate SoT

Time frame: Through study completion, an average of 6 months

Sensitivity of each PET/CT imaging agent in tumor detection on a patient-basis confirmed by SoT or surrogate SoT

Time frame: Through study completion, an average of 6 months

Positive and negative predictive values (PPV, NPV) of each PET/CT imaging agent to detect tumor on a patient-basis and lesion-basis

Time frame: Through study completion, an average of 6 months

Detection rate of each PET/CT imaging agent to detect tumor on a patient-basis and lesion-basis confirmed by SoT or surrogate SoT

Time frame: Through study completion, an average of 6 months

Proportion of patients with additional or less tumoral lesions detected by [68Ga]Ga-PTF PET/CT imaging compared to [18F]FDG PET/CT imaging

Time frame: Through study completion, an average of 6 months

Inter-reader and intra-reader agreement for tumor detection of each PET/CT imaging agent on a lesion-basis and patient-basis

Time frame: Through study completion, an average of 6 months

Reproducibility of [68Ga]Ga-PTF PET/CT imaging (reproducibility group)

Time frame: Through study completion, an average of 6 months

Maximum standardized uptake value (SUVmax), SUVpeak and SUV mean of each PET/CT imaging agent

Time frame: Through study completion, an average of 6 months

Target-to-background ratio (TBR) of each PET/CT imaging agent

Time frame: Through study completion, an average of 6 months

Contrast-to-noise ratio (CNR) of each PET/CT imaging agent

Time frame: Through study completion, an average of 6 months

Signal-to-noise ratio (CNR) of each PET/CT imaging agent

Time frame: Through study completion, an average of 6 months

Frequency and Severity of Adverse Events for each PET/CT imaging agent

Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent

Frequency and kind of adverse effects present at the injection site

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of the injection site status (which kind of adverse effects have appeared) after the injection of each PET/CT imaging compound

Time frame: 2-3 hours after injection of each PET/CT imaging agent

Clinical significance of abnormal results during physical examination

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of physical examination findings

Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent

Blood pressure (systolic and diastolic)

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of blood pressure (systolic and diastolic)

Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent

Heart or pulse rate

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of heart or pulse rate

Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent

RR interval findings/abnormalities

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of findings/abnormalities in the RR interval

Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent

PQ interval findings/abnormalities

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of PQ interval findings/abnormalities

Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent

QRS complex findings/abnormalities

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QRS complex findings/abnormalities

Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent

QT interval findings/abnormalities

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QT interval findings/abnormalities

Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent

QTc interval findings/abnormalities

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of QTc interval findings/abnormalities

Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent

Weight

The safety and tolerability for each PET/CT imaging agent will be evaluated by the assessment of patient weight

Time frame: Prior injection of each PET/CT imaging agent and after injection of each PET/CT imaging agent