Ended Therapeutic confirmatory (Phase III) Marginal Zone Lymphoma

[68Ga]Ga-PentixaFor-PET imaging for staging of marginal zone lymphoma

EU CTIS ID: 2022-500918-25-00

What this study is testing

1. To assess the superiority in terms of sensitivity and non-inferiority in terms of specificity of [68Ga]Ga-PTF PET/CT imaging vs. [18F]FDG PET/CT imaging in tumor detection on a lesion-basis confirmed by a Standard of Truth (SoT; centrally histopathological confirmation of tumor tissue) or surrogate SoT (central evaluation clinical and imaging follow-up).

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

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 4th revised edition of the World Health Organization HAEM4R classification of lymphoid neoplasms as well as established MZL stage. Patients must have a biopsy-proven nodal, extranodal, or splenic MZL (at the time of enrolment, the CXCR4 expression status will be unknown). The biopsy used for MZL diagnosis (diagnostic biopsy) must not be collected more than 12 weeks before Visit 1.
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

You likely can't join if

1. Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PTF and/or [18F]FDG product
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.
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.
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

See the full eligibility criteria

Who can join

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 4th revised edition of the World Health Organization HAEM4R classification of lymphoid neoplasms as well as established MZL stage. Patients must have a biopsy-proven nodal, extranodal, or splenic MZL (at the time of enrolment, the CXCR4 expression status will be unknown). The biopsy used for MZL diagnosis (diagnostic biopsy) must not be collected more than 12 weeks before Visit 1.
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 (refer to Protocol for complete information)
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

What rules you out

1. Known hypersensitivity to any active pharmaceutical agent or constituent of the [68Ga]Ga-PTF and/or [18F]FDG product
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.
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.
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
13. 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)
14. Body weight of less than 48 kg
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 with plasma glucose levels higher than 11 mmol/L or 200 mg/dL prior [18F]FDG administration.
5. Administration of any anticancer therapy within 1 month prior to study entry.
6. Patients with complete resection of the tumor lesion(s)
15. Any other concurrently active neoplasia, or other disease who could jeopardize study safety or data.
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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.