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NCT Number: NCT05400967

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

FAP is a fibroblast activation protein and overexpressed in many tumor tissues. This study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177Lu-EB-FAPI--a new 177Lu therapeutic drug modified by Evans Blue (EB) for the first time in the world.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Rongxi Wang

CONTACT

[email protected]

+86 19800370331

About this study

Fibroblast activation protein (FAP) is a serine peptidase on the surface of tumor associated fibroblasts. It belongs to type II transmembrane glycoprotein. It is rich and characteristic expressed in tumor associated fibroblasts. It has special biological characteristics and stable genome. FAP is expressed at a high level in mesenchymal cells during the embryonic period and is inhibited shortly after birth. It is 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, such as wound healing, inflammatory response, fibrosis and cancer It plays an important role in metastasis and immunosuppression.Currently, 68Ga labeled FAPI (68Ga-FAPI) has been successfully applied to a variety of tumor PET/CT imaging, including lung cancer, breast cancer, and gastrointestinal tract tumors.By modifying FAPI with Evans blue (EB) to form a new EB-FAPI, endogenous albumin can be used as a reversible carrier to prolong the retention time of drugs in the blood, thus increasing the targeted aggregation and retention of 177Lu-EB-FAPI in tumor cells, and effectively killing a variety of transplanted tumors with positive FAP expression.we'll try to assess the safety and therapeutic response to 177Lu-EB-FAPI 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 for PET / CT scan and 177Lu-EB-FAPI for therapy

Drug

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

Primary outcomes

  1. Safety of therapy

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

    the safety assessed by CTCAE v4.0

  2. Therapeutic effect

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

    the therapeutic response assessed by 68Ga-FAPI PET/CT to 177Lu-EB-FAPI in patients with metastatic tumors

Secondary outcomes

  1. Diagnostic value

    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

Study contacts

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

Rongxi Wang

CONTACT

[email protected]

+8619800370331

Zhaohui Zhu

CONTACT

[email protected]

86-13611093752

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2022
Registry last updated
Sep 19, 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.