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

NCT ID: NCT04689893

Last Updated: 2021-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-15
• Study Completion Date: 2022-03-15

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.

Conditions

Tumor-Induced Osteomalacia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT scan

Patients of Tumor-induced osteomalacia PET/CT imaging: The patients were subcutaneously injected with 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 and underwent PET/CT scan 20\~40min after the injection in two consecutive days.

Group Type: EXPERIMENTAL

68Ga-Dotatate

Intervention Type: DRUG

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

68Ga-DOTA-JR11

Intervention Type: DRUG

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

Interventions

68Ga-Dotatate

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

Intervention Type: DRUG

68Ga-DOTA-JR11

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

Intervention Type: DRUG

Other Intervention Names

68Ga-Dotatate injection; 68Ga-DOTA-JR11 injection

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongli Jing, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking union medical college hospital

Beijing, Dongcheng, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guozhu Hou, MD

Role: CONTACT

15611145656@163.com

15611145656

Facility Contacts

Guozhu Hou

Role: primary

15611145656@163.com

15611145656

References

Hou G, Zhang Y, Liu Y, Wang P, Xia W, Xing X, Huo L, Li F, Jing H. Head-to-Head Comparison of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in Patients With Tumor-Induced Osteomalacia: A Prospective Study. Front Oncol. 2022 Feb 24;12:811209. doi: 10.3389/fonc.2022.811209. eCollection 2022.

Reference Type: DERIVED

PMID: 35280786 (View on PubMed)

Other Identifiers

PUMCHTIOJR11

Identifier Type: -

Identifier Source: org_study_id