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NCT Number: NCT06461182

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

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.

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Key information

Conditions

Indolent B-Cell Non-Hodgkin Lymphoma

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ga-68-CXCR4

Drug

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

Other names: PET/CT

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: up to 24 months

    McNemar test, Two-tailed，P<.05

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

    Time frame: up to 24 months

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

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

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Cheng Ling Yang, B.Rad.

CONTACT

[email protected]

+886 28970011 ext. 1167

Yu Yi Huang, MD

CONTACT

[email protected]

+886 28970011 ext. 1121

Sponsors and collaborators

Lead sponsor

Koo Foundation Sun Yat-Sen Cancer Center

Other

Registry information

Official study title

Ga-68-CXCR4 PET/CT in Detecting, Evaluating Response to Treatment, and Monitoring Risk of Aggressiveness of Indolent B-cell Lymphoma

Acronym: PentixaFor

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 14, 2024
Registry last updated
Jun 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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