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

Last updated: January 2, 2021
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Musculoskeletal Diseases

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT04689893
PUMCHTIOJR11
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • pregnancy;
  • breastfeeding;
  • any medical condition that in the opinion of the investigator may significantlyinterfere with study compliance.

Study Design

Total Participants: 50
Study Start date:
March 15, 2020
Estimated Completion Date:
March 15, 2022

Study 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.

Connect with a study center

  • Peking union medical college hospital

    Beijing, Dongcheng 100010
    China

    Active - Recruiting

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