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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05549024
• Other study ID #: PUMCH-NM-RR
• Status: Recruiting
• Phase: Early Phase 1
• Start date: August 16, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, MD,PHD
• Phone: 86+13611093752
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumor
• Breast Cancer
• PET/CT Imaging
• Prostate Cancer

Intervention

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.
• 18F-FDG
18F-FDG injection
• 68Ga-RM26
Intravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
• 68Ga-RGD
Intravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic performance1	comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 18F-FDG PET/CT	through study completion, an average of 1 year
Primary	Diagnostic performance2	comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RM26 PET/CT	through study completion, an average of 1 year
Primary	Diagnostic performance3	comparing the SUV and number of primary or metastasis lesions detected by 68Ga-RM26-RGD and 68Ga-RGD PET/CT	through study completion, an average of 1 year
Secondary	The dosimetry of 68Ga-RM26-RGD	Measure the distribution of 68Ga-RM26-RGD in GRPR and avß3 positive tumor patients by 2-hour dynamic PET/CT acquisition by dosimetry software	through study completion, an average of 1 year
Secondary	68Ga-RM26-RGD uptake at different tumors	The SUV uptake of tumors and metastases in patients with breast/brain/prostate cancer was measured.	through study completion, an average of 1 year