NCT04689893

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Tumor-Induced Osteomalacia

Interventions

Type	Name	Description
DRUG	68Ga-Dotatate	68Ga-Dotatate was injected into the patients before the PET/CT scans
DRUG	68Ga-DOTA-JR11	68Ga-DOTA-JR11 was injected into the patients before the PET/CT scans

Timeline

• Start date: 2020-03-15
• Primary completion: 2021-03-15
• Completion: 2022-03-15
• First posted: 2020-12-30
• Last updated: 2021-01-05

Locations

1 site across 1 country: China