Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma (PentixaFor)

Koo Foundation Sun Yat-Sen Cancer Center

Status and phase: Enrolling; Phase 2

Conditions: Indolent B-Cell Non-Hodgkin Lymphoma

Treatments: Drug: Ga-68-CXCR4

Study type: Interventional

Funder types: Other

Identifiers

NCT06461182

KF-CXCR4-001

Details and patient eligibility

About

This study explores the efficacy of Ga-68-PentixaFor PET/CT in detecting, assessing treatment response, and monitoring the risk of aggressiveness in indolent B-cell lymphoma. The background introduces CXCR4 and discusses its role in cancer research. Currently, FDG-PET is the primary imaging tool for lymphoma staging, but it lacks diagnostic accuracy for low-grade lymphomas. Ga-68-PentixaFor PET demonstrates promising detection capabilities across various lymphomas, suggesting its potential as a superior imaging modality for low-grade lymphomas.

Enrollment: 15 estimated patients

Sex: All

Ages: 20 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• The pathological diagnosis is slow-growing lymphoma, such as: marginal-zone B-cell lymphoma, Waldenstrom macroglobulinemia lymphocytic lymphoma, CLL/SLL, mantle cell lymphoma.
• Have undergone or planned to undergo FDG PET scan for indications including initial staging, therapeutic response evaluation, or follow-up examinations within 3 to 6 months in the clinical observation group.
• Able to lie flat for at least 30 minutes.
• Signing the subject consent form.
• ECOG grade 0-2.
• The timing of F-18-FDG usage in this trial follows the "Lymphoma Treatment Principles" of our institution.

Exclusion criteria

• Pregnant woman
• Severe renal impairment (eGRF< 30ml/min)
• Known or suspected allergy to radiopharmaceuticals
• Concurrent or previous diagnosis of malignancies other than lymphoma
• Inability to undergo the necessary PET scan procedure
• Refusal or unwillingness to sign the informed consent form
• Severe medical conditions (severe disabilities, mental disorders)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma

Experimental group

Description:

Indolent B-cell Lymphoma such as marginal-zone B-cell lymphoma、Waldenstrom macroglobulinemia lymphocytic lymphoma、CLL/SLL、mantle cell lymphoma.

Treatment:

Drug: Ga-68-CXCR4