Application of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in the Diagnosis and Evaluation of TIO
Primary Purpose
Tumor-Induced Osteomalacia
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-Dotatate
68Ga-DOTA-JR11
Sponsored by
About this trial
This is an interventional diagnostic trial for Tumor-Induced Osteomalacia
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.
Sites / Locations
- Peking union medical college hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT scan
Arm Description
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.
Outcomes
Primary Outcome Measures
Diagnostic value
Sensitivity and Specificity of 68Ga-DOTA-JR11 PET/CT for TIO in comparison with 68Ga-DOTATATE PET/CT
Secondary Outcome Measures
Full Information
NCT ID
NCT04689893
First Posted
December 28, 2020
Last Updated
January 2, 2021
Sponsor
Peking Union Medical College Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04689893
Brief Title
Application of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in the Diagnosis and Evaluation of TIO
Official Title
Head-to-head Comparison of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in Patients With Tumor-induced Osteomalacia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 15, 2020 (Actual)
Primary Completion Date
March 15, 2021 (Anticipated)
Study Completion Date
March 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tumor-Induced Osteomalacia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT scan
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
68Ga-Dotatate
Other Intervention Name(s)
68Ga-Dotatate injection
Intervention Description
68Ga-Dotatate was injected into the patients before the PET/CT scans
Intervention Type
Drug
Intervention Name(s)
68Ga-DOTA-JR11
Other Intervention Name(s)
68Ga-DOTA-JR11 injection
Intervention Description
68Ga-DOTA-JR11 was injected into the patients before the PET/CT scans
Primary Outcome Measure Information:
Title
Diagnostic value
Description
Sensitivity and Specificity of 68Ga-DOTA-JR11 PET/CT for TIO in comparison with 68Ga-DOTATATE PET/CT
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guozhu Hou, MD
Phone
15611145656
Email
15611145656@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongli Jing, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking union medical college hospital
City
Beijing
State/Province
Dongcheng
ZIP/Postal Code
100010
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guozhu Hou
Phone
15611145656
Email
15611145656@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
35280786
Citation
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.
Results Reference
derived
Learn more about this trial
Application of 68Ga-DOTA-TATE and 68Ga-DOTA-JR11 PET/CT in the Diagnosis and Evaluation of TIO
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