A Study to Evaluate a New Way to Identify/Diagnose Tumours With Somatostatin Receptors Using 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
A 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 (Ga-DOTATATE) is more accurate than an Octreoscan™. This study will look at Ga-HA-DOTATATE scans, a product virtually identical to Ga-DOTATATE.
The purpose of this study is to: 1) demonstrate the safety of Ga-HA-DOTATATE; and 2) confirm that Ga-HA-DOTATATE is effective at diagnosing somatostatin positive tumours.
|Condition or disease||Intervention/treatment||Phase|
|Neuroendocrine Tumors||Drug: Ga-HA-DOTATATE||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Study of Gallium-68 HA-DOTATATE (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|
All participants will be imaged with Ga-HA-DOTATATE PET/CT for uptake by somatostatin receptor positive tumours.
All participants will be injected with Ga-HA-DOTATATE approximately 60 minutes before PET/CT scan.
- Change in vital signs after Ga-HA-DOTATATE injection (first 10 patients) [ Time Frame: Before Ga-HA-DOTATATE injection and after Ga-HA-DOTATATE scan (within ~30 min) ]Vital signs are measured before injection of Ga-HA-DOTATATE and after Ga-HA-DOTATATE scan and changes will be summarized.
- Changes in haematology / SMA-12 serum biochemistry after Ga-HA-DOTATATE injection (first 10 patients) [ Time Frame: Before Ga-HA-DOTATATE injection and after Ga-HA-DOTATATE scan (within ~30 min) ]A blood sample is drawn before injection of Ga-HA-DOTATATE and after Ga-HA-DOTATATE scan. The haematology and SMA-12 serum biochemistry parameters will be recorded and all changes will be summarized.
- Number of participants with adverse events [ Time Frame: Up to 1 year ]All participants will be evaluated for AE occurrence once the Ga-HA-DOTATATE has been administered for AEs occuring within 24 h.
- Correlation of Ga-HA-DOTATATE scan with standard of care cross-sectional imaging [ Time Frame: Up to 1 year ]Correlation of 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].
- Correlation of Ga-HA-DOTATATE scan with values published in the literature [ Time Frame: Up to 1 year ]Correlation of Ga-HA-DOTATATE scan with values published in the literature for diagnostic effectiveness.
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
|Contact: Cindy Duncan||780-577-8080||ACB.NeuroEndocrine@ahs.ca|
|Contact: Marguerite Wieler, BScPT, PhD||780-391-7634||Marguerite.Wieler@ahs.ca|
|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|
|Principal Investigator:||Alexander (Sandy) JB McEwan, MB, FRCPC||Professor, Department of Oncology|