68Ga-RM26-RGD PET/CT Imaging in the GRPR and αvβ3 Positive Tumor Patients
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
pregnancy;
breastfeeding;
any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Trial design
Design model
Single group
Treatments tested in this trial
68Ga-RM26-RGD
DrugIntravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
18F-FDG
Drug18F-FDG injection
68Ga-RM26
DrugIntravenous injection of 68Ga-RM26-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
68Ga-RGD
DrugIntravenous injection of 68Ga-RGD with a dosage of approximately 1.8-2.2 MBq (0.05-0.06 mCi)/ kg.
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: 68Ga-RM26-RGD and 18F-FDG PET/ CT scanExperimental treatment 2 interventions
Group B: 68Ga-RM26-RGD and 68Ga-RM26 PET/ CT scanExperimental treatment 2 interventions
Group C: 68Ga-RM26-RGD and 68Ga-RGD PET/ CT scanExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Diagnostic performance1
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 year2
Diagnostic performance2
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 year3
Diagnostic performance3
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 yearSecondary outcomes
1
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
Time frame
through study completion, an average of 1 year2
68Ga-RM26-RGD uptake at different tumors
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov