Diagnosis of Metastatic Tumors on 68Ga-FAPI PET-CT and Radioligand Therapy With 177Lu-EB-FAPI
Primary Purpose
177Lu-EB-FAPI
Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-FAPI for PET / CT scan and 177Lu-EB-FAPI for therapy
Sponsored by
About this trial
This is an interventional treatment trial for 177Lu-EB-FAPI
Eligibility Criteria
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
Sites / Locations
- Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-FAPI PET/CT for scan and 177Lu-EB- FAPI for therapy
Arm Description
All patients diagnosed with metastatic tumors underwent 68Ga-FAPI PET/CT scan. If the PET/CT showed high FAPI expression in tumor lesions of some patients, they would intravenously injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-FAPI for therapy.
Outcomes
Primary Outcome Measures
Safety of therapy
the safety assessed by CTCAE v4.0
Therapeutic effect
the therapeutic response assessed by 68Ga-FAPI PET/CT to 177Lu-EB-FAPI in patients with metastatic tumors
Secondary Outcome Measures
Diagnostic value
Sensitivity and Specificity of 68Ga-FAPI PET/CT for metastatic tumors in comparison with 18F-FDG PET/CT
Full Information
NCT ID
NCT05400967
First Posted
February 10, 2022
Last Updated
May 27, 2022
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05400967
Brief Title
Diagnosis of Metastatic Tumors on 68Ga-FAPI PET-CT and Radioligand Therapy With 177Lu-EB-FAPI
Official Title
Diagnosis of Metastatic Tumors on 68Ga-FAPI PET-CT and Radioligand Therapy With 177Lu-EB-FAPI
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
177Lu-EB-FAPI
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-FAPI PET/CT for scan and 177Lu-EB- FAPI for therapy
Arm Type
Experimental
Arm Description
All patients diagnosed with metastatic tumors underwent 68Ga-FAPI PET/CT scan. If the PET/CT showed high FAPI expression in tumor lesions of some patients, they would intravenously injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-FAPI for therapy.
Intervention Type
Drug
Intervention Name(s)
68Ga-FAPI for PET / CT scan and 177Lu-EB-FAPI for therapy
Intervention Description
Patients with positive results were screened with 68Ga-FAPI PET / CT, and 1.11GBq(30mci) 177Lu-EB-FAPI was injected intravenously for therapy after contraindications were excluded and informed consent was signed.
Primary Outcome Measure Information:
Title
Safety of therapy
Description
the safety assessed by CTCAE v4.0
Time Frame
through study completion, an average of 1 year
Title
Therapeutic effect
Description
the therapeutic response assessed by 68Ga-FAPI PET/CT to 177Lu-EB-FAPI in patients with metastatic tumors
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Diagnostic value
Description
Sensitivity and Specificity of 68Ga-FAPI PET/CT for metastatic tumors in comparison with 18F-FDG PET/CT
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu
Phone
86-13611093752
Email
13611093752@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Rongxi Wang
Phone
+8619800370331
Email
pumch_jacobwong@163.com
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rongxi Wang
Phone
+86 19800370331
Email
pumch_jacobwong@163.com
12. IPD Sharing Statement
Learn more about this trial
Diagnosis of Metastatic Tumors on 68Ga-FAPI PET-CT and Radioligand Therapy With 177Lu-EB-FAPI
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