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Trial record 6 of 59 for:    somatostatin receptor | Neuroendocrine Tumors

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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ClinicalTrials.gov Identifier: NCT03145857
Recruitment Status : Not yet recruiting
First Posted : May 9, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Alexander McEwan, University of Alberta

Brief Summary:

A [68]Ga-HA-DOTATATE PET/CT 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 Octreoscan™. 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 scans, 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 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 Phase I/II, diagnostic imaging, controlled, open label, single site, single dose clinical trial 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 for uptake by somatostatin receptor positive tumours. A safety evaluation will be conducted on the first 10 consecutively enrolled participants (safety sub-group), consisting of vital signs, haematology and SMA-12 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 the remaining participants will consist of an AE assessment (up to 24 hours) after [68]Ga-HA-DOTATATE imaging. The efficacy evaluation will include [68]Ga-HA-DOTATATE scan clinical accuracy compared to standard of care cross-sectional images and values published in the literature.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: [68]Ga-HA-DOTATATE
All participants will be imaged with [68]Ga-HA-DOTATATE PET/CT for uptake by somatostatin receptor positive tumours.
Drug: [68]Ga-HA-DOTATATE
All participants will be injected with [68]Ga-HA-DOTATATE approximately 60 minutes before PET/CT scan.
Other Names:
  • Gallium-68 high affinity-DOTATATE
  • Gallium-68 DOTA-3-iodo-Tyr(3)-octreotate




Primary Outcome Measures :
  1. Change in vital signs after [68]Ga-HA-DOTATATE injection (first 10 patients) [ Time Frame: Before [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min) ]
    Vital signs are measured before injection of [68]Ga-HA-DOTATATE and after [68]Ga-HA-DOTATATE scan and changes will be summarized.

  2. Changes in haematology / SMA-12 serum biochemistry after [68]Ga-HA-DOTATATE injection (first 10 patients) [ Time Frame: Before [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min) ]
    A blood sample is drawn before injection of [68]Ga-HA-DOTATATE and after [68]Ga-HA-DOTATATE scan. The haematology and SMA-12 serum biochemistry parameters will be recorded and all changes will be summarized.

  3. Number of participants with adverse events [ Time Frame: Up to 1 year ]
    All participants will be evaluated for AE occurrence once the [68]Ga-HA-DOTATATE has been administered for AEs occuring within 24 h.

  4. Correlation of [68]Ga-HA-DOTATATE scan with standard of care cross-sectional imaging [ Time Frame: Up to 1 year ]
    Correlation of [68]Ga-HA-DOTATATE scan with standard of care cross-sectional imaging [including CT, MRI, 111 In-pentetreotide (OctreoscanTM) SPECT, 18F-FDG PET/CT, as available].

  5. Correlation of [68]Ga-HA-DOTATATE scan with values published in the literature [ Time Frame: Up to 1 year ]
    Correlation of [68]Ga-HA-DOTATATE scan with values published in the literature for diagnostic effectiveness.



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Ages Eligible for Study:   18 Years and older   (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. Supporting evidence may include MRI, CT, biochemical markers, OctreoscanTM, 18F-FDG PET/CT and/or pathology report from surgery or biopsy;
  2. Eastern Cooperative Oncology Group (ECOG) Performance Scale Score ≤2
  3. At least 18 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. Prior external beam radiation therapy to only known site of disease;
  5. Pregnant or breast-feeding.
  6. Allergic reaction to DOTATATE or somatostatin analogues.

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: Cindy Duncan 780-577-8080 ACB.NeuroEndocrine@ahs.ca
Contact: Marguerite Wieler, BScPT, PhD 780-391-7634 Marguerite.Wieler@ahs.ca

Locations
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Canada, Alberta
Cross Cancer Institute Not yet recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Sub-Investigator: Todd McMullen, MD, PhD, FRCSC, FACS         
Sub-Investigator: Donald Morrish, MD, PhD, FRCPC         
Sub-Investigator: Michael Sawyer, MD, FRCPC         
Sub-Investigator: Marguerite Wieler, BScPT, PhD         
Sub-Investigator: Terence Riauka, PhD         
Sponsors and Collaborators
Alexander McEwan
Investigators
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Principal Investigator: Alexander (Sandy) JB McEwan, MB, FRCPC Professor, Department of Oncology

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Responsible Party: Alexander McEwan, Professor, Department of Oncology, University of Alberta
ClinicalTrials.gov Identifier: NCT03145857     History of Changes
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: October 15, 2018
Last Verified: October 2018
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 Alexander McEwan, University of Alberta:
Gallium-68
Positron Emission Tomography

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
Somatostatin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs