To hear about similar clinical trials, please enter your email below
Trial Title:
68Ga-DOTATATE PET/CT for the Diagnosis of Soft Tissue Sarcomas
NCT ID:
NCT06500065
Condition:
Soft Tissue Sarcoma
Conditions: Official terms:
Sarcoma
1,4,7,10-tetraazacyclododecane- 1,4,7,10-tetraacetic acid
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo dPET/CT
Arm group label:
Diagnostic (68Ga-DOTATATE dPET/CT)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Radiation
Intervention name:
Gallium Ga 68-HA-DOTA-TATE
Description:
Given IV
Arm group label:
Diagnostic (68Ga-DOTATATE dPET/CT)
Other name:
68Ga-DOTA-3-iodo-Tyr3-octreotate
Other name:
68Ga-DOTA-iodoTyr3-octreotate
Other name:
68Ga-HA-DOTATATE
Other name:
[68Ga]DOTA-3-iodo-Tyr3-octreotate
Other name:
[68Ga]high-affinity DOTATATE
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo dPET/CT
Arm group label:
Diagnostic (68Ga-DOTATATE dPET/CT)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Summary:
This trial studies how well 68Ga-DOTATATE digital PET/CT 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 patient's body. 68Ga-DOTATATE digital PET/CT 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 dPET/CT
and 18F-FDG dPET/CT 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 dPET/CT 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 dPET/CT over
60 minutes up to two weeks after starting standard chemotherapy. Beginning 24 hours after
gallium Ga 68-HA-DOTA-TATE dPET/CT, patients also receive fludeoxyglucose F-18 IV and
undergo dPET/CT over 60 minutes.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients >= 18 years of age
- Patients diagnosed with any stage of soft tissue sarcomas candidates for systemic
therapies
- Patients with one standard of care PET/CT scan up to 30 days before enrollment at
the Ohio State University facilities.
Exclusion Criteria:
- Hypersensitivity to somatostatin or similar peptides
- Somatostatin long-acting analog in the past 6 months
- Patients who are pregnant or lactating
- Patients who are currently incarcerated
- Patients with acute infections
- Inability to complete the needed investigational and standard-of-care imaging
examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Patients exceeding the weight limitations of the scanner or are not able to enter
the bore of the dPET/CT scanner due to body mass index (BMI)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ohio State University Comprehensive Cancer Center
Address:
City:
Columbus
Zip:
43210
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gabriel R. Tinoco Suarez
Phone:
614-293-0109
Email:
Gabriel.Tinoco@osumc.edu
Investigator:
Last name:
Gabriel R. Tinoco Suarez
Email:
Principal Investigator
Start date:
May 1, 2024
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Ohio State University Comprehensive Cancer Center
Agency class:
Other
Source:
Ohio State University Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06500065
