Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06500065
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-08
Brief Title:
68Ga-DOTATATE PETCT for the Diagnosis of Soft Tissue Sarcomas
Sponsor:
Ohio State University Comprehensive Cancer Center
Organization:
Ohio State University Comprehensive Cancer Center
Study Overview
Official Title:
Clinical Feasibility and Potential Clinical Benefit of 68Ga-DOTATATE PETCT Assessment of Soft Tissue Sarcomas for Potential Peptide Receptor Radionuclide Therapy
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial studies how well 68Ga-DOTATATE digital PETCT work in diagnosing soft tissue sarcoma 68Ga-DOTATATE is a radiotracer that may improve image quality of PET imaging PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer in the case of this research 68Ga-DOTATATE CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patients body 68Ga-DOTATATE digital PETCT may work better in imaging patients with soft tissue sarcomas
Detailed Description:
PRIMARY OBJECTIVE
I To assess the feasibility and capability of gallium Ga 68-HA-DOTA-TATE 68Ga-DOTATATE digital positron emission tomography dPET computed tomography CT imaging for soft tissue sarcomas
SECONDARY OBJECTIVES
I To evaluate the clinical benefit of 68Ga-DOTATATE for a comprehensive assessment of soft tissue sarcomas STS using next-generation digital PET detector technology
II To describe the perfusion and early tumor uptake kinetics of tumor targets at baseline and following conventional systemic therapy using both 68Ga-DOT AT A TE dPETCT and 18F-FDG dPETCT approaches
III Using list-mode dPET acquisitions following standard 68Ga-DOTATATE dose administrations imaging datasets will be retrospectively generated to simulate lower dose or faster image acquisition in order to define further the minimum 68Ga-DOTATATE dose and PET image acquisition times needed to maintain lesion detectability and PET quantification
V To assess the feasibility for 68Ga-DOTATATE dPETCT to identify and stratify STS patients with SSTR2-positive soft tissue sarcoma lesions for future therapy planning using 177Lu-DOTATATE peptide receptor radionuclide therapy PRRT for patients with 68Ga-DOTATATE-avid sarcomas
VI To assess the safety of 68Ga-DOTATATE in this patient population
OUTLINE
Patients receive gallium Ga 68-HA-DOTA-TATE intravenously IV and undergo dPETCT over 60 minutes up to two weeks after starting standard chemotherapy Beginning 24 hours after gallium Ga 68-HA-DOTA-TATE dPETCT patients also receive fludeoxyglucose F-18 IV and undergo dPETCT over 60 minutes
I To assess the feasibility and capability of gallium Ga 68-HA-DOTA-TATE 68Ga-DOTATATE digital positron emission tomography dPET computed tomography CT imaging for soft tissue sarcomas
SECONDARY OBJECTIVES
I To evaluate the clinical benefit of 68Ga-DOTATATE for a comprehensive assessment of soft tissue sarcomas STS using next-generation digital PET detector technology
II To describe the perfusion and early tumor uptake kinetics of tumor targets at baseline and following conventional systemic therapy using both 68Ga-DOT AT A TE dPETCT and 18F-FDG dPETCT approaches
III Using list-mode dPET acquisitions following standard 68Ga-DOTATATE dose administrations imaging datasets will be retrospectively generated to simulate lower dose or faster image acquisition in order to define further the minimum 68Ga-DOTATATE dose and PET image acquisition times needed to maintain lesion detectability and PET quantification
V To assess the feasibility for 68Ga-DOTATATE dPETCT to identify and stratify STS patients with SSTR2-positive soft tissue sarcoma lesions for future therapy planning using 177Lu-DOTATATE peptide receptor radionuclide therapy PRRT for patients with 68Ga-DOTATATE-avid sarcomas
VI To assess the safety of 68Ga-DOTATATE in this patient population
OUTLINE
Patients receive gallium Ga 68-HA-DOTA-TATE intravenously IV and undergo dPETCT over 60 minutes up to two weeks after starting standard chemotherapy Beginning 24 hours after gallium Ga 68-HA-DOTA-TATE dPETCT patients also receive fludeoxyglucose F-18 IV and undergo dPETCT over 60 minutes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2020-11528 | REGISTRY | None | None |