Ga-68-CXCR4 PET/CT in Indolent B-cell Lymphoma
ConditionIndolent B-Cell Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age20-100
SponsorKoo Foundation Sun Yat-Sen Cancer Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant woman
Severe renal impairment (eGRF< 30ml/min)
Known or suspected allergy to radiopharmaceuticals
Concurrent or previous diagnosis of malignancies other than lymphoma
Trial design
Design model
Single group
Treatments tested in this trial
Ga-68-CXCR4
DrugGa-68-CXCR4 for PET/CT procedure in Indolent B-cell Lymphoma
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Ga-68-CXCR4 PET/CT in Indolent B-cell LymphomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Ga-68-CXCR4 compared to F-18-FDG PET/CT
McNemar test, Two-tailed，P\<.05
Time frame
up to 24 months2
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 months3
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 monthsSponsors and contacts
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Source ClinicalTrials.gov