A Dual-targeting Tracer TATE-RGD for the Diagnosis of SSTR- and RGD- Positive Tumors
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPeking Union Medical College Hospital
About this trial
The US FDA approved a targeted somatostatin receptor 2 imaging agent, 68Ga-DOTATATE, in 2016. It has higher uptake in small cell lung cancer, pulmonary carcinoid, and medullary thyroid cancer. Integrin αvβ3 is highly expressed in some tumor cells and new blood vessels, making it an ideal target for targeted diagnosis and treatment of tumors and tumor vessels.68Ga-labeled DOTA-TATE-RGD is a new type of tumor-specific imaging agent developed by researchers based on the above foundation, which is used for targeted diagnosis and internal radiation therapy for patients with SSTR2 and αvβ3 positive tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
histologically confirmed various cancer patients;
68Ga-TATE-RGD and 18F-FDG PET/CT within a week;
signed written consent.
Disqualifiers
known allergy against TATE-RGD;
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-TATE-RGD
DrugIntravenous injection of 68Ga-TATE-RGD with the dosage of 1.8-2.2 MBq (0.05-0.06 mCi)/kg. Tracer doses will be used to image lesions of by dual-targeted postive cancers PET/CT.
18-FDG
DrugIntravenous injection of 18F-FDG with the dosage of 1.8-2.2 MBq(0.12-0.15mCi/kg). Tracer doses will be used to lesions therapy of dual-targeted postive cancers by SPECT/CT.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Experimental: 68Ga-TATE-RGD PET/ CT scanExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Tumor detection rate
comparing the number of tumor detected by 68Ga-TATE-RGD and18F-FDG PET/CT
Time frame
through study completion, an average of half-yearSecondary outcomes
1
standardized uptake value (SUV) of tumor
comparing the SUVmax of tumor derived from 68Ga-TATE-RGD and 18F-FDG PET/CT
Time frame
through study completion, an average of half-yearSponsors and contacts
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Source ClinicalTrials.gov