Indolent B-Cell Non-Hodgkin Lymphoma
Conditions
Keywords
Ga-68-CXCR4 PET/CT, indolent B-cell lymphoma
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.
Interventions
DRUGGa-68-CXCR4
Ga-68-CXCR4 for PET/CT procedure in Indolent B-cell Lymphoma
Sponsors
Koo Foundation Sun Yat-Sen Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ga-68-CXCR4 compared to F-18-FDG PET/CT | up to 24 months | McNemar test, Two-tailed，P\<.05 |
| 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 |
| 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). |
Countries
Taiwan
Contacts
Primary ContactYu Yi Huang, MD
Backup ContactCheng Ling Yang, B.Rad.
Outcome results
None listed