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

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05549024
Collaborator
(none)
90
1
3
16.5
5.5

Study Details

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients
Actual Study Start Date :
Aug 16, 2022
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: 68Ga-RM26-RGD and 18F-FDG PET/ CT scan

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

Drug: 68Ga-RM26-RGD
Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
Other Names:
  • 68Ga-RM26-RGD injection
  • Drug: 18F-FDG
    18F-FDG injection
    Other Names:
  • Intravenous injection of 18F-FDG with a dosage of approximately 3.7-5.55 MBq (0.1-0.15 mCi)/kg.
  • Experimental: 68Ga-RM26-RGD and 68Ga-RM26 PET/ CT scan

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

    Drug: 68Ga-RM26-RGD
    Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
    Other Names:
  • 68Ga-RM26-RGD injection
  • Drug: 68Ga-RM26
    Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
    Other Names:
  • 68Ga-RM26 injection
  • Experimental: 68Ga-RM26-RGD and 68Ga-RGD PET/ CT scan

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

    Drug: 68Ga-RM26-RGD
    Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
    Other Names:
  • 68Ga-RM26-RGD injection
  • Drug: 68Ga-RGD
    Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
    Other Names:
  • 68Ga-RGD injection
  • Outcome Measures

    Primary Outcome Measures

    1. Diagnostic performance1 [through study completion, an average of 1 year]

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

    2. Diagnostic performance2 [through study completion, an average of 1 year]

      comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RM26 PET/CT

    3. Diagnostic performance3 [through study completion, an average of 1 year]

      comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RGD PET/CT

    Secondary Outcome Measures

    1. The dosimetry of 68Ga-RM26-RGD [through study completion, an average of 1 year]

      Measure the distribution of 68Ga-RM26-RGD in GRPR and αvβ3 positive tumor patients by 2-hour dynamic PET/CT acquisition by dosimetry software

    2. 68Ga-RM26-RGD uptake at different tumors [through study completion, an average of 1 year]

      The SUV uptake of tumors and metastases in patients with breast/brain/prostate cancer was measured.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking Union Medical College Hospital Beijing China

    Sponsors and Collaborators

    • Peking Union Medical College Hospital

    Investigators

    • Principal Investigator: Zhaohui Zhu, MD,PHD, Peking Union Medical College Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Peking Union Medical College Hospital
    ClinicalTrials.gov Identifier:
    NCT05549024
    Other Study ID Numbers:
    • PUMCH-NM-RR
    First Posted:
    Sep 22, 2022
    Last Update Posted:
    Sep 22, 2022
    Last Verified:
    Sep 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 22, 2022