Application of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in the Diagnosis and Evaluation of TIO

Tumor-Induced Osteomalacia Clinical Trial

Official title:

Head-to-head Comparison of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in Patients With Tumor-induced Osteomalacia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04689893
• Other study ID #: PUMCHTIOJR11
• Status: Recruiting
• Phase: Phase 1
• Start date: March 15, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: December 2020
• Source: Peking Union Medical College Hospital
• Contact: Guozhu Hou, MD
• Phone: 15611145656
• Email: 15611145656[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label whole-body PET/CT study for investigating the value of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in patients with Tumor-induced osteomalacia.

Description:

Tumor-induced osteomalacia (TIO), also known as oncogenic osteomalacia, is a rare paraneoplastic syndrome. The key to the cure of TIO is surgical resection of the culprit tumor. Over the last decade, 68Ga-labeled SSTR-based imaging has made a significant impact in detecting the culprit tumor of TIO 68Ga-DOTA-TATE is the most used SSTR PET tracer for the detection of TIO and it was recommended as first-line imaging method for localization of the causative tumor. However, false positive, including fracture and/or inflammation, in 68Ga-DOTA-TATE PET/CT is a challenge in image interpretation, which may make the causative tumor indistinguishable in multiple suspicious lesions. There is no effective way to identify multiple suspicious lesions with intensive increased uptake on 68Ga-DOTA-TATE PET/CT. 68Ga-DOTA-JR11 is a SSTR2 specific antagonist used for PET tracer. However, the SSTR2 affinity of 68Ga-DOTA-JR11 is lower than 68Ga-DOTA-TATE, which means that the uptake of 68Ga-DOTA-JR11 by suspected lesions may be lower than that of 68Ga-DOTA-TATE. The purpose of this prospective study is to compare the sensitivity of 68Ga-DOTA-JR11 and 68Ga-DOTA-TATE PET/CT for detecting the responsible tumor of TIO and investigate if 68Ga-DOTA-JR11 PET/CT can identify the culprit tumor of TIO in multiple suspicious lesions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 15, 2022
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• suspected or confirmed untreated TIO patients;
• 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT within two weeks;
• 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

• Neoplasms, Connective Tissue
• Osteomalacia
• Tumor-Induced Osteomalacia

Intervention

Drug:
• 68Ga-Dotatate
68Ga-Dotatate was injected into the patients before the PET/CT scans
• 68Ga-DOTA-JR11
68Ga-DOTA-JR11 was injected into the patients before the PET/CT scans

Locations

Country	Name	City	State
China	Peking union medical college hospital	Beijing	Dongcheng

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 value	Sensitivity and Specificity of 68Ga-DOTA-JR11 PET/CT for TIO in comparison with 68Ga-DOTATATE PET/CT	through study completion, an average of 1 year