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
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Mar 2020
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2020
CompletedFirst Submitted
Initial submission to the registry
December 28, 2020
CompletedFirst Posted
Study publicly available on registry
December 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2022
CompletedJanuary 5, 2021
December 1, 2020
1 year
December 28, 2020
January 2, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT scan
EXPERIMENTALPatients 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.
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
Eligibility Criteria
You may qualify if:
- suspected or confirmed untreated TIO patients;
- Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT within two weeks;
- signed written consent.
You may not qualify if:
- pregnancy;
- breastfeeding;
- any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking union medical college hospital
Beijing, Dongcheng, 100010, China
Related Publications (1)
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.
PMID: 35280786DERIVED
MeSH Terms
Conditions
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Hongli Jing, MD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2020
First Posted
December 30, 2020
Study Start
March 15, 2020
Primary Completion
March 15, 2021
Study Completion
March 15, 2022
Last Updated
January 5, 2021
Record last verified: 2020-12