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68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients

Primary Purpose

Breast Cancer, Prostate Cancer, Brain Tumor

Status
Recruiting
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-RM26-RGD
18F-FDG
68Ga-RM26
68Ga-RGD
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients with confirmed or suspected breast/brain/prostate cancer;
  • 68Ga-RM26-RGD and 18F-FDG(or 68Ga-RM26 or 68Ga-RGD) PET/CT within 2 week;
  • 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 HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

68Ga-RM26-RGD and 18F-FDG PET/ CT scan

68Ga-RM26-RGD and 68Ga-RM26 PET/ CT scan

68Ga-RM26-RGD and 68Ga-RGD PET/ CT scan

Arm Description

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 18F-FDG, respectively.

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 68Ga-RM26, respectively.

Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 68Ga-RGD, respectively.

Outcomes

Primary Outcome Measures

Diagnostic performance1
comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 18F-FDG PET/CT
Diagnostic performance2
comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RM26 PET/CT
Diagnostic performance3
comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RGD PET/CT

Secondary Outcome Measures

The dosimetry of 68Ga-RM26-RGD
Measure the distribution of 68Ga-RM26-RGD in GRPR and αvβ3 positive tumor patients by 2-hour dynamic PET/CT acquisition by dosimetry software
68Ga-RM26-RGD uptake at different tumors
The SUV uptake of tumors and metastases in patients with breast/brain/prostate cancer was measured.

Full Information

First Posted
September 18, 2022
Last Updated
September 18, 2022
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05549024
Brief Title
68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients
Official Title
68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 16, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 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
Based on the high expression of specific receptors on the surface of diseased tissues and neovascularization, noninvasive targeted molecular imaging can be used to visualize lesions in vitro by combining specific ligands labeled with short half-life isotopes. In this study, a novel dual-target imaging agent 68Ga-RM26-RGD was used for clinical study of tumor PET/CT imaging to further verify its clinical application value.
Detailed Description
Conventional 18F-FDG PET/CT has important diagnostic value in cell metabolism level, early metastasis, judging malignant potential and prognosis of tumors. It has been routinely used for staging and restaging of most tumors, but there are still some tumors with low uptake of 18F-FDG PET/CT. 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 GRPr 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 such as breast\brain\prostate tumor which have high GRPr and αvβ3 receptor expression . In this study, a novel dual-target imaging agent 68Ga-RM26-RGD was used for PET/CT imaging of breast\brain\prostate cancer, compared with conventional 18F-FDG, or single target imaging agent 68Ga-RGD or 68Ga-RM26 PET/CT imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer, Brain Tumor, PET/CT Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-RM26-RGD and 18F-FDG PET/ CT scan
Arm Type
Experimental
Arm Description
Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 18F-FDG, respectively.
Arm Title
68Ga-RM26-RGD and 68Ga-RM26 PET/ CT scan
Arm Type
Experimental
Arm Description
Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 68Ga-RM26, respectively.
Arm Title
68Ga-RM26-RGD and 68Ga-RGD PET/ CT scan
Arm Type
Experimental
Arm Description
Within 2 week, each patient underwent PET/CT scan after intravenous administration of 68Ga-RM26-RGD and 68Ga-RGD, respectively.
Intervention Type
Drug
Intervention Name(s)
68Ga-RM26-RGD
Other Intervention Name(s)
68Ga-RM26-RGD injection
Intervention Description
Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
Intervention Type
Drug
Intervention Name(s)
18F-FDG
Other Intervention Name(s)
Intravenous injection of 18F-FDG with a dosage of approximately 3.7-5.55 MBq (0.1-0.15 mCi)/kg.
Intervention Description
18F-FDG injection
Intervention Type
Drug
Intervention Name(s)
68Ga-RM26
Other Intervention Name(s)
68Ga-RM26 injection
Intervention Description
Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
Intervention Type
Drug
Intervention Name(s)
68Ga-RGD
Other Intervention Name(s)
68Ga-RGD injection
Intervention Description
Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
Primary Outcome Measure Information:
Title
Diagnostic performance1
Description
comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 18F-FDG PET/CT
Time Frame
through study completion, an average of 1 year
Title
Diagnostic performance2
Description
comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RM26 PET/CT
Time Frame
through study completion, an average of 1 year
Title
Diagnostic performance3
Description
comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RGD PET/CT
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
The dosimetry of 68Ga-RM26-RGD
Description
Measure the distribution of 68Ga-RM26-RGD in GRPR and αvβ3 positive tumor patients by 2-hour dynamic PET/CT acquisition by dosimetry software
Time Frame
through study completion, an average of 1 year
Title
68Ga-RM26-RGD uptake at different tumors
Description
The SUV uptake of tumors and metastases in patients with breast/brain/prostate cancer was measured.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients with confirmed or suspected breast/brain/prostate cancer; 68Ga-RM26-RGD and 18F-FDG(or 68Ga-RM26 or 68Ga-RGD) PET/CT within 2 week; 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, MD,PHD
Phone
86+13611093752
Email
13611093752@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaohui Zhu, MD,PHD
Phone
86+19800370331
Email
pumch_jacobwong@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD,PHD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD,PHD
Phone
86+13611093752
Email
13611093752@163.com

12. IPD Sharing Statement

Learn more about this trial

68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients

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