Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma
- Registration Number
- NCT06461182
- Lead Sponsor
- Koo Foundation Sun Yat-Sen Cancer Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 15
- 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.
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma Ga-68-CXCR4 Indolent B-cell Lymphoma such as marginal-zone B-cell lymphoma、Waldenstrom macroglobulinemia lymphocytic lymphoma、CLL/SLL、mantle cell lymphoma.
- Primary Outcome Measures
Name Time Method Performance of Ga-68-CXCR4 PET/CT in indolent B cell lymphoma up to 24 months 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
- Secondary Outcome Measures
Name Time Method Ga-68-CXCR4 compared to F-18-FDG PET/CT up to 24 months McNemar test, Two-tailed，P\<.05
Prognostic value of Ga-68-CXCR4 PET/CT scan up to 36 months 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).Clinical impact of Ga-68-CXCR4 compared to F-18-FDG PET/CT up to 24 months Treatment plan questionnaires before and after Ga-68-CXCR4 PET/CT
Trial Locations
- Locations (1)
Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳Taipei, Beitou, Taiwan