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Recruiting NCT05549024

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

Early Phase I Interventional Breast Cancer Prostate Cancer Brain Tumor PET/CT Imaging

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 68Ga-RM26-RGD, 18F-FDG, 68Ga-RM26, 68Ga-RGD.
Who it may be relevant to
Registry conditions: Breast Cancer, Prostate Cancer, Brain Tumor, PET/CT Imaging. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.
  • Drug 18F-FDG
    18F-FDG 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.
  • Drug 68Ga-RGD
    Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.

Primary outcome measures

  • Diagnostic performance1 [Time frame: through study completion, an average of 1 year]
  • Diagnostic performance2 [Time frame: through study completion, an average of 1 year]
  • Diagnostic performance3 [Time frame: through study completion, an average of 1 year]
Secondary outcome measures (2)
  • The dosimetry of 68Ga-RM26-RGD [Time frame: through study completion, an average of 1 year]
  • 68Ga-RM26-RGD uptake at different tumors [Time frame: through study completion, an average of 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT05549024 · PUMCH-NM-RR

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗