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NCT Number: NCT06638034

Diagnosis of Metastatic Tumors on 68Ga-FAPI-RGD PET-CT and Radioligand Therapy With 177Lu-FAPI-RGD

FAP and RGD are overexpressed in many tumor tissues. This study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177Lu-FAPI-RGD--a new dual-targeted 177Lu therapeutic drug for the first time in the world.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Chinese Academy of Medical Science & Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Zhaohui Zhu, MD

CONTACT

[email protected]

+8613051615100

About this study

Fibroblast activation protein (FAP) and RGD are serine peptidase on the surface of tumor associated fibroblasts. It has special biological characteristics and stable genome. They are usually not expressed or expressed at a low level in the resting tissues of normal adults, but it is highly expressed in diseases related to tissue repair and matrix reconstruction,Receptor imaging with a single target also has some limitations in clinical application. For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. The dual-target molecular imaging based on FAP expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors and used to 177Lu PRRT. We'll try to assess the safety and therapeutic response to 177Lu-FAPI-RGD in patients with metastatic tumors in human.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • confirmed treated or untreated metastatic tumors patients;
  • 68Ga-FAPI PET/CT and 18F-FDG PET/CT within two weeks;
  • signed written consent.

Exclusion criteria

  • pregnancy;
  • breastfeeding;
  • any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Treatment and study plan

68Ga-FAPI-RGD for PET / CT scan and 177Lu-FAPI-RGD for therapy

Drug

Patients with positive results were screened with 68Ga-FAPI PET / CT, and 2.22-3.33GBq(60mci-100mCi) 177Lu-FAPI-RGD was injected intravenously for therapy after contraindications were excluded and informed consent was signed.

Primary outcomes

  1. tandarStandardized uptake value of 177Lu-TATE-RGD in normal organs and tumors.

    Time frame: through study completion, an average of half-year

    The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value at each time point in normal organs and tumors will be measured.

  2. Adverse events collection

    Time frame: through study completion, an average of 2 months

    Adverse events within 2 months after the injection and scanning of patients will be followed and assessed.

Secondary outcomes

  1. SUVmax, SUVmean, lesion-based analysis

    Time frame: through study completion, an average of 1 year

    Sensitivity and Specificity of 68Ga-FAPI PET/CT for metastatic tumors in comparison with 18F-FDG PET/CT, including some semi-quantative quota for lesion-based analysis, such as SUVmax, SUVmean

Study contacts

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

Zhaohui Zhu, MD

CONTACT

[email protected]

13611093752

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Diagnosis of Metastatic Tumors on 68Ga-FAPI-RGD PET-CT and Radioligand Therapy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 15, 2024
Registry last updated
Oct 15, 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.