A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use
Primary Purpose
Neuroendocrine Tumors
Status
Recruiting
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
[68]Ga-HA-DOTATATE
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumors focused on measuring Gallium-68, Positron Emission Tomography, 68Ga-HA-DOTATATE
Eligibility Criteria
Inclusion Criteria:
- Known or suspected somatostatin receptor positive tumour including, but not limited to, GNET, PNET, pulmonary NET, PRUNK NET, pheochromocytoma, paraganglioma, medullary thyroid cancer, and medulloblastoma. A standard CT or MRI obtained within 6 months of enrolment is required. Additional supporting evidence obtained within 12 months of enrolment may include: other standard imaging (In-111 octreotide (Octreoscan), [18]F-FDG PET, or [18]F-FDOPA PET); histopathology from surgery or biopsy; elevated biochemical markers (including Chromogranin A, 5-HIAA, insulin, vasoactive intestinal peptide (VIP), glucagon, gastrin, metanephrines, and/or others, as clinically indicated); and/or persistent carcinoid-like symptomology highly suspicious for the presence of NET even in absence of pathologic imaging findings by anatomic criteria;
- Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 3 within 2 weeks of enrolment;
- At least 14 years of age;
- Able and willing to follow instructions and comply with the protocol;
- Ability to provide written informed consent prior to participation in the study.
Exclusion Criteria:
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
- Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation;
- Weight exceeding the PET/CT or PET/MR scanner limit;
- Pregnancy;
- Allergic reaction to DOTATATE or somatostatin analogues.
Sites / Locations
- Cross Cancer InstituteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[68]Ga-HA-DOTATATE
Arm Description
All participants will be imaged with [68]Ga-HA-DOTATATE PET/CT or PET/MRI for uptake by somatostatin receptor positive tumours. Up to seven [68]Ga-HA-DOTATATE scans may be performed per participant, as clinically indicated.
Outcomes
Primary Outcome Measures
Change in vital signs after first [68]Ga-HA-DOTATATE injection (safety sub-group)
Vital signs are measured before first injection of [68]Ga-HA-DOTATATE and after [68]Ga-HA-DOTATATE scan and changes will be summarized.
Changes in haematology and biochemistry after first [68]Ga-HA-DOTATATE injection (safety sub-group)
A blood sample is drawn before first injection of [68]Ga-HA-DOTATATE and after [68]Ga-HA-DOTATATE scan. The haematology and biochemistry parameters will be recorded and all changes will be summarized.
Number of participants with adverse events within 24 hours (safety sub-group)
Participants will be evaluated for AE occurrence once the [68]Ga-HA-DOTATATE has been administered for AEs occuring within 24 h of first scan.
Number of participants with adverse events
Participants will be evaluated for AE occurrence once the [68]Ga-HA-DOTATATE has been administered for AEs occuring while in the Nuclear Medicine Department.
Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care CT or MRI
[68]Ga-HA-DOTATATE scans will be evaluated for abnormal accumulation of [68]Ga-HA-DOTATATE. The maximum Standardized Uptake Value (SUVmax) will be determined for up to 5 lesions and compared to results of baseline standard of care CT or MRI for presence/absence of each lesion. An overall assessment of the correlation between [68]Ga-HA-DOTATATE PET/CT or PET/MRI and baseline CT/MRI will be made.
Secondary Outcome Measures
Evaluation of [68]Ga-HA-DOTATATE scan changes compared to baseline scan
As applicable, follow-up [68]Ga-HA-DOTATATE scans will be evaluated for abnormal accumulation of [68]Ga-HA-DOTATATE. The maximum Standardized Uptake Value (SUVmax) will be determined for the target lesions identified at baseline and compared to the results of the baseline [68]Ga-HA-DOTATATE. An overall assessment of the correlation between the follow-up and baseline scan will be made.
Full Information
NCT ID
NCT03145857
First Posted
May 5, 2017
Last Updated
January 17, 2023
Sponsor
AHS Cancer Control Alberta
1. Study Identification
Unique Protocol Identification Number
NCT03145857
Brief Title
A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use
Official Title
A Phase I/II Study of Gallium-68 HA-DOTATATE ([68]Ga-HA-DOTATATE) in Patients With Known or Suspected Somatostatin Receptor Positive Tumours
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 5, 2020 (Actual)
Primary Completion Date
December 2031 (Anticipated)
Study Completion Date
December 2031 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AHS Cancer Control Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A [68]Ga-HA-DOTATATE PET/CT or PET/MRI scan is a nuclear medicine test used to create pictures of the whole body that will show where somatostatin receptors are found, including on tumours. Somatostatin receptors are found on most neuroendocrine tumours (NETs), and some other types of tumours. Currently at the Cross Cancer Institute, most patients with suspected somatostatin positive tumours (e.g. NETs) have an In-111 Octreotide (Octreoscan™) scan. A scientific study has shown that a scan with a similar product ([68]Ga-DOTATATE) is more accurate than an Octreoscan™. This study will look at [68]Ga-HA-DOTATATE, a product virtually identical to [68]Ga-DOTATATE.
The purpose of this study is to: 1) demonstrate the safety of [68]Ga-HA-DOTATATE; and 2) confirm that [68]Ga-HA-DOTATATE PET/CT or PET/MRI is effective at diagnosing somatostatin positive tumours.
Detailed Description
The proposed clinical trial will be a sequential Phase I/II, diagnostic imaging, controlled, open label, single site study in a broad cross-section of patients with known or suspected somatostatin receptor positive tumours. All participants will be imaged with [68]Ga-HA-DOTATATE PET/CT or PET/MRI for uptake by somatostatin receptor positive tumours. Up to seven [68]Ga-HA-DOTATATE scans may be performed per participant, as clinically indicated. A safety evaluation will be conducted on the first 10 consecutively enrolled participants (safety sub-group), consisting of vital signs, haematology and serum biochemistry profile (pre-injection and post-imaging), and an adverse event (AE) assessment (up to 24 hours) after [68]Ga-HA-DOTATATE imaging. The safety evaluation for subsequent [68]Ga-HA-DOTATATE scan visits for participants in the safety sub-group and for the remaining participants will consist of an AE assessment while in the Nuclear Medicine department. The efficacy evaluation will include [68]Ga-HA-DOTATATE scan clinical accuracy compared to standard of care CT or MRI.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumors
Keywords
Gallium-68, Positron Emission Tomography, 68Ga-HA-DOTATATE
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[68]Ga-HA-DOTATATE
Arm Type
Experimental
Arm Description
All participants will be imaged with [68]Ga-HA-DOTATATE PET/CT or PET/MRI for uptake by somatostatin receptor positive tumours. Up to seven [68]Ga-HA-DOTATATE scans may be performed per participant, as clinically indicated.
Intervention Type
Drug
Intervention Name(s)
[68]Ga-HA-DOTATATE
Other Intervention Name(s)
Gallium-68 high affinity-DOTATATE, Gallium-68 DOTA-3-iodo-Tyr(3)-octreotate
Intervention Description
All participants will be injected with [68]Ga-HA-DOTATATE approximately 60 minutes before PET/CT or PET/MRI scan.
Primary Outcome Measure Information:
Title
Change in vital signs after first [68]Ga-HA-DOTATATE injection (safety sub-group)
Description
Vital signs are measured before first injection of [68]Ga-HA-DOTATATE and after [68]Ga-HA-DOTATATE scan and changes will be summarized.
Time Frame
Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min)
Title
Changes in haematology and biochemistry after first [68]Ga-HA-DOTATATE injection (safety sub-group)
Description
A blood sample is drawn before first injection of [68]Ga-HA-DOTATATE and after [68]Ga-HA-DOTATATE scan. The haematology and biochemistry parameters will be recorded and all changes will be summarized.
Time Frame
Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min)
Title
Number of participants with adverse events within 24 hours (safety sub-group)
Description
Participants will be evaluated for AE occurrence once the [68]Ga-HA-DOTATATE has been administered for AEs occuring within 24 h of first scan.
Time Frame
Within 24 hours of [68]Ga-HA-DOTATATE scan completion
Title
Number of participants with adverse events
Description
Participants will be evaluated for AE occurrence once the [68]Ga-HA-DOTATATE has been administered for AEs occuring while in the Nuclear Medicine Department.
Time Frame
Up to 2 hours after [68]Ga-HA-DOTATATE administration
Title
Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care CT or MRI
Description
[68]Ga-HA-DOTATATE scans will be evaluated for abnormal accumulation of [68]Ga-HA-DOTATATE. The maximum Standardized Uptake Value (SUVmax) will be determined for up to 5 lesions and compared to results of baseline standard of care CT or MRI for presence/absence of each lesion. An overall assessment of the correlation between [68]Ga-HA-DOTATATE PET/CT or PET/MRI and baseline CT/MRI will be made.
Time Frame
Up to 6 years
Secondary Outcome Measure Information:
Title
Evaluation of [68]Ga-HA-DOTATATE scan changes compared to baseline scan
Description
As applicable, follow-up [68]Ga-HA-DOTATATE scans will be evaluated for abnormal accumulation of [68]Ga-HA-DOTATATE. The maximum Standardized Uptake Value (SUVmax) will be determined for the target lesions identified at baseline and compared to the results of the baseline [68]Ga-HA-DOTATATE. An overall assessment of the correlation between the follow-up and baseline scan will be made.
Time Frame
Up to 6 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Known or suspected somatostatin receptor positive tumour including, but not limited to, GNET, PNET, pulmonary NET, PRUNK NET, pheochromocytoma, paraganglioma, medullary thyroid cancer, and medulloblastoma. A standard CT or MRI obtained within 6 months of enrolment is required. Additional supporting evidence obtained within 12 months of enrolment may include: other standard imaging (In-111 octreotide (Octreoscan), [18]F-FDG PET, or [18]F-FDOPA PET); histopathology from surgery or biopsy; elevated biochemical markers (including Chromogranin A, 5-HIAA, insulin, vasoactive intestinal peptide (VIP), glucagon, gastrin, metanephrines, and/or others, as clinically indicated); and/or persistent carcinoid-like symptomology highly suspicious for the presence of NET even in absence of pathologic imaging findings by anatomic criteria;
Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 3 within 2 weeks of enrolment;
At least 14 years of age;
Able and willing to follow instructions and comply with the protocol;
Ability to provide written informed consent prior to participation in the study.
Exclusion Criteria:
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
Any additional medical condition, serious inter-current illness or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study performance or interpretation;
Weight exceeding the PET/CT or PET/MR scanner limit;
Pregnancy;
Allergic reaction to DOTATATE or somatostatin analogues.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
NET Coordinator
Phone
780-577-8080
Email
ACB.NeuroEndocrine@ahs.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd PW McMullen, MD, PhD, FRCSC, FACS
Organizational Affiliation
Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stella Koumna, MD
First Name & Middle Initial & Last Name & Degree
Daniel Thut, MD
First Name & Middle Initial & Last Name & Degree
Donald W Morrish, MD, PhD, FRCPC
First Name & Middle Initial & Last Name & Degree
Michael B Sawyer, MD, BSc Phm, FRCPC
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using [68]Ga-HA-DOTATATE and to Ensure it is Safe to Use
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