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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
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04689893
Enrollment
50
Registered
2020-12-30
Start date
2020-03-15
Completion date
2022-03-15
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tumor-Induced Osteomalacia

Brief 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.

Interventions

68Ga-Dotatate was injected into the patients before the PET/CT scans

68Ga-DOTA-JR11 was injected into the patients before the PET/CT scans

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic valuethrough study completion, an average of 1 yearSensitivity and Specificity of 68Ga-DOTA-JR11 PET/CT for TIO in comparison with 68Ga-DOTATATE PET/CT

Countries

China

Contacts

Primary ContactGuozhu Hou, MD
15611145656@163.com15611145656

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026