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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03145857
Recruitment Status : Recruiting
First Posted : May 9, 2017
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
AHS Cancer Control Alberta

Study Description
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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.


Condition or disease Intervention/treatment Phase
Neuroendocrine Tumors Drug: [68]Ga-HA-DOTATATE Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : March 5, 2020
Estimated Primary Completion Date : December 2031
Estimated Study Completion Date : December 2031

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Nuclear Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: [68]Ga-HA-DOTATATE
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.
 Drug: [68]Ga-HA-DOTATATE
All participants will be injected with [68]Ga-HA-DOTATATE approximately 60 minutes before PET/CT or PET/MRI scan.
Other Names:
  • Gallium-68 high affinity-DOTATATE
  • Gallium-68 DOTA-3-iodo-Tyr(3)-octreotate


Outcome Measures
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Primary Outcome Measures :
  1. Change in vital signs after first [68]Ga-HA-DOTATATE injection (safety sub-group) [ Time Frame: Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min) ]
    Vital signs are measured before first injection of [68]Ga-HA-DOTATATE and after [68]Ga-HA-DOTATATE scan and changes will be summarized.

  2. Changes in haematology and biochemistry after first [68]Ga-HA-DOTATATE injection (safety sub-group) [ Time Frame: Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min) ]
    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.

  3. Number of participants with adverse events within 24 hours (safety sub-group) [ Time Frame: Within 24 hours of [68]Ga-HA-DOTATATE scan completion ]
    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.

  4. Number of participants with adverse events [ Time Frame: Up to 2 hours after [68]Ga-HA-DOTATATE administration ]
    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.

  5. Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care CT or MRI [ Time Frame: Up to 6 years ]
    [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 :
  1. Evaluation of [68]Ga-HA-DOTATATE scan changes compared to baseline scan [ Time Frame: Up to 6 years ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤ 3 within 2 weeks of enrolment;
  3. At least 14 years of age;
  4. Able and willing to follow instructions and comply with the protocol;
  5. Ability to provide written informed consent prior to participation in the study.

Exclusion Criteria:

  1. Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.);
  2. Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.);
  3. 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;
  4. Weight exceeding the PET/CT or PET/MR scanner limit;
  5. Pregnancy;
  6. Allergic reaction to DOTATATE or somatostatin analogues.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03145857


Contacts
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Contact: NET Coordinator 780-577-8080 ACB.NeuroEndocrine@ahs.ca

Locations
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Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Sub-Investigator: Stella Koumna, MD         
Sub-Investigator: Daniel Thut, MD         
Sub-Investigator: Donald W Morrish, MD, PhD, FRCPC         
Sub-Investigator: Michael B Sawyer, MD, BSc Phm, FRCPC         
Sponsors and Collaborators
AHS Cancer Control Alberta
Investigators
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Principal Investigator: Todd PW McMullen, MD, PhD, FRCSC, FACS Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology
More Information
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Responsible Party: AHS Cancer Control Alberta
ClinicalTrials.gov Identifier: NCT03145857    
Other Study ID Numbers: DX-GAL-001
HREBA.CC-16-1013 ( Other Identifier: Health Research Ethics Board of Alberta Cancer Committee )
First Posted: May 9, 2017    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AHS Cancer Control Alberta:
Gallium-68
Positron Emission Tomography
68Ga-HA-DOTATATE
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue