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

Phase 2RecruitingNCT06461182

Koo Foundation Sun Yat-Sen Cancer Center15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Indolent B-Cell Non-Hodgkin Lymphoma

Interventions

Ga-68-CXCR4

Eligibility

Sex: ALLMin age: 20 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Performance of Ga-68-CXCR4 PET/CT in indolent B cell lymphoma

Detection rate = number of positive scan / total number of scan Sensitivity = number of true positive scan / total number of proven recurrent patient Specificity = number of true negative scan / total number of proven free of disease patient Accuracy = number of (true positive scan + true negative scan) / total number of scan Positive predictive value = number of true positive scan / number of positive scan Negative predictive value = number of true negative scan / number of negative scan

Time frame: up to 24 months

Secondary Outcomes

Ga-68-CXCR4 compared to F-18-FDG PET/CT

McNemar test, Two-tailed，P\<.05

Time frame: up to 24 months

Clinical impact of Ga-68-CXCR4 compared to F-18-FDG PET/CT

Treatment plan questionnaires before and after Ga-68-CXCR4 PET/CT

Time frame: up to 24 months

Prognostic value of Ga-68-CXCR4 PET/CT scan

The correlation between the radiomic features of Ga-68-CXCR4 PET/CT scan and progression free survival. CXCR4 radiomics : Feature extraction was performed with the open-source Python package pyradiomics. For each volume of interest (VOI), including first-order statistics, shape features, grey level co-occurrence matrix (GLCM), grey level run length matrix (GLRLM), grey level size-zone matrix (GLSZM), neighborhood grey level different matrix (NGLDM), and grey level dependence matrix (GLDM).

Time frame: up to 36 months

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts