Back to results177Lu-AB-3PRGD2 in Patients With Non Small Cell Lung Cancer
Primary Purpose
Non Small Cell Lung Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
1.11 GBq of 177Lu-AB-3PRGD2
Sponsored by
About this trial
This is an interventional treatment trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- confirmed NSCLC patients;
- tumor lesions with high RGD untake confirmed on 68Ga-RGD PET/CT within one week before the injection of 177Lu-AB-3PRGD2;
- signed written consent.
Exclusion Criteria:
- the exclusion criteria were a serum creatinine level of more than 150 μmol per liter, a hemoglobin level of less than 10.0 g/dl, a white-cell count of less than 4.0× 109/L, a platelet count of less than 100 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1.11 GBq of 177Lu-AB-3PRGD2
Arm Description
The patients were intravenously injected with the dose about 1.11GBq (30 mCi) of 177Lu-AB-3PRGD2 and underwent 68Ga-RGD PET/CT scans before and after the treatment.
Outcomes
Primary Outcome Measures
StandarStandardized uptake value of 177Lu-AB-3PRGD2 in normal organs and NSCLC.
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 NSCLC will be measured.
Secondary Outcome Measures
Adverse events collection
Adverse events within 2 months after the injection and scanning of patients will be followed and assessed.
Full Information
NCT ID
NCT05013086
First Posted
August 13, 2021
Last Updated
October 15, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05013086
Brief Title
177Lu-AB-3PRGD2 in Patients With Non Small Cell Lung Cancer
Official Title
Therapeutic Efficiency and Response to 177Lu-AB-3PRGD2 in Patients With Non Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
June 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
This is an open-label, non-controlled, non-randomized study to assess the safety and measure image-based absorbed dose of 177Lu-AB-3PRGD2 in patients with Non Small Cell Lung Cancerr (NSCLC) who will undergo radioliagnd therapy using 177Lu-AB-3PRGD.
Detailed Description
Integrin αvβ3 is highly expressed in some tumor cells and neovascularization, which is an ideal target for diagnosis and treatment of NSCLC. 177Lu-AB-3PRGD2, is a kind of new drug based on independent research and development in China, provide an effective target for the treatment of NSCLC. All patients underwent whole-body 68Ga-RGD PET/CT for selection and accepted intravenous injection with single dose 1.11 GBq (30 mCi) of 177Lu-AB-3PRGD2 within one week. 1-2 ml venous blood was collected at 30min, 60min, 120min, 1d, 3d, 5d and 7d after administration to detect radioactivity count, respectively. Then monitored at 2, 24, 72, 120 and 168 h after 177Lu-AB-3PRGD2 administration with serial whole body planar and SPECT/CT imaging. Analyze and calculate the internal radiation dose of 177Lu-AB-3PRGD2 and evaluate its therapeutic efficiency and response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer
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
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1.11 GBq of 177Lu-AB-3PRGD2
Arm Type
Experimental
Arm Description
The patients were intravenously injected with the dose about 1.11GBq (30 mCi) of 177Lu-AB-3PRGD2 and underwent 68Ga-RGD PET/CT scans before and after the treatment.
Intervention Type
Drug
Intervention Name(s)
1.11 GBq of 177Lu-AB-3PRGD2
Intervention Description
accepted intravenous injection of 177Lu-AB-3PRGD2
Primary Outcome Measure Information:
Title
StandarStandardized uptake value of 177Lu-AB-3PRGD2 in normal organs and NSCLC.
Description
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 NSCLC will be measured.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events collection
Description
Adverse events within 2 months after the injection and scanning of patients will be followed and assessed.
Time Frame
2 months
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 NSCLC patients;
tumor lesions with high RGD untake confirmed on 68Ga-RGD PET/CT within one week before the injection of 177Lu-AB-3PRGD2;
signed written consent.
Exclusion Criteria:
the exclusion criteria were a serum creatinine level of more than 150 μmol per liter, a hemoglobin level of less than 10.0 g/dl, a white-cell count of less than 4.0× 109/L, a platelet count of less than 100 × 109/L, a total bilirubin level of more than 3 times the upper limit of the normal range and a serum albumin level of more than 3.0 g per deciliter, cardiac insufficiency including carcinoid heart valve disease, a severe allergy or hypersensitivity to radiographic contrast material, claustrophobia;
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, MD
Phone
86-13611093752
Email
13611093752@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guochang Wang, MD
Phone
86-18516822732
Email
guochang1007@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD
Phone
86-13611093752
Email
13611093752@163.com
First Name & Middle Initial & Last Name & Degree
Guochang Wang, MD
Phone
86-18516822732
Email
guochang1007@163.com
12. IPD Sharing Statement
Learn more about this trial
177Lu-AB-3PRGD2 in Patients With Non Small Cell Lung Cancer
We'll reach out to this number within 24 hrs