Back to results68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Primary Purpose
Neuroendocrine Tumors
Status
Recruiting
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
68Ga-HA-DOTATATE
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumors
Eligibility Criteria
Inclusion Criteria:
- Patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma
- A standard clinical CT or MRI is obtained within 6 months of enrollment
- Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker)
Exclusion Criteria:
- Weight > 225 kg (weight limit of the PET/CT scanner)
- Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging
- Any additional medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation
- Previous allergic reaction to DOTATATE or somatostatin analogues
- Lack of intravenous access
Sites / Locations
- University of AlbertaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-HA-DOTATATE PET/CT scan
Arm Description
2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging
Outcomes
Primary Outcome Measures
Efficacy - sensitivity
Sensitivity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
Efficacy - specificity
Specificity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
Secondary Outcome Measures
Safety - adverse events - immediate
Assessment of adverse events immediately after tracer injection
Safety - adverse events - post-scan
Assessment of adverse events immediately after PET/CT scan
Safety - adverse events - delayed
Self-reporting of possible adverse events after leaving the PET department
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04888481
Brief Title
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Official Title
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
August 31, 2027 (Anticipated)
Study Completion Date
August 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumors. In the past, 111In-octreotide imaging has been used for this purpose but it has been recently supplanted globally by SSR positron emission tomography (PET) imaging due to better image quality and higher diagnostic accuracy.
This study will assess the safety and diagnostic effectiveness of 68Ga-HA-DOTATATE produced a the Edmonton Radiopharmaceutical Centre (ERC).
Detailed Description
A single centre non-randomized, non-blinded phase II prospective cohort study evaluating the safety and efficacy of 68Ga-HA-DOTATATE PET/CT imaging in patients with known or suspected somatostatin receptor positive tumors.
Up to 600 scans will be included over 6 years. All patient ages (pediatric and adult) will be included. Individual patients may have more than one scan during the study period.
Safety evaluation will consist of an adverse event assessment whil in the Nuclear Medicine department at the University of Alberta Hospital. Efficacy evaluation will consist of a comparison to CT and/or MRI accuracy based on 1 year follow-up clinical evaluation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-HA-DOTATATE PET/CT scan
Arm Type
Experimental
Arm Description
2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging
Intervention Type
Drug
Intervention Name(s)
68Ga-HA-DOTATATE
Intervention Description
Tracer injection
Primary Outcome Measure Information:
Title
Efficacy - sensitivity
Description
Sensitivity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
Time Frame
1 year post-scan
Title
Efficacy - specificity
Description
Specificity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up
Time Frame
1 year post-scan
Secondary Outcome Measure Information:
Title
Safety - adverse events - immediate
Description
Assessment of adverse events immediately after tracer injection
Time Frame
Immediately (within 15 minutes) after tracer injection
Title
Safety - adverse events - post-scan
Description
Assessment of adverse events immediately after PET/CT scan
Time Frame
Immediately (within 15 minutes) after PET/CT scan; 60 to 100 minutes after tracer injection
Title
Safety - adverse events - delayed
Description
Self-reporting of possible adverse events after leaving the PET department
Time Frame
10 days after tracer injection
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma
A standard clinical CT or MRI is obtained within 6 months of enrollment
Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker)
Exclusion Criteria:
Weight > 225 kg (weight limit of the PET/CT scanner)
Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging
Any additional medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation
Previous allergic reaction to DOTATATE or somatostatin analogues
Lack of intravenous access
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Abele, MD
Phone
780-407-6907
Email
jabele@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Abele, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Abele, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors
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