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 : August 22, 2019
A 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 (Ga-DOTATATE) is more accurate than an Octreoscan™. This study will look at Ga-HA-DOTATATE, 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 PET/CT or PET/MRI 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 :||500 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 :||November 2019|
|Estimated Primary Completion Date :||December 2031|
|Estimated Study Completion Date :||December 2031|
All participants will be imaged with Ga-HA-DOTATATE PET/CT or PET/MRI for uptake by somatostatin receptor positive tumours. Up to seven Ga-HA-DOTATATE scans may be performed per participant, as clinically indicated.
All participants will be injected with Ga-HA-DOTATATE approximately 60 minutes before PET/CT or PET/MRI scan.
- Change in vital signs after first Ga-HA-DOTATATE injection (safety sub-group) [ Time Frame: Before first Ga-HA-DOTATATE injection and after Ga-HA-DOTATATE scan (within ~30 min) ]Vital signs are measured before first injection of Ga-HA-DOTATATE and after Ga-HA-DOTATATE scan and changes will be summarized.
- Changes in haematology and biochemistry after first Ga-HA-DOTATATE injection (safety sub-group) [ Time Frame: Before first Ga-HA-DOTATATE injection and after Ga-HA-DOTATATE scan (within ~30 min) ]A blood sample is drawn before first injection of Ga-HA-DOTATATE and after 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) [ Time Frame: Within 24 hours of Ga-HA-DOTATATE scan completion ]Participants will be evaluated for AE occurrence once the Ga-HA-DOTATATE has been administered for AEs occuring within 24 h of first scan.
- Number of participants with adverse events [ Time Frame: Up to 2 hours after Ga-HA-DOTATATE administration ]Participants will be evaluated for AE occurrence once the Ga-HA-DOTATATE has been administered for AEs occuring while in the Nuclear Medicine Department.
- Correlation of Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care CT or MRI [ Time Frame: Up to 6 years ]Ga-HA-DOTATATE scans will be evaluated for abnormal accumulation of 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 Ga-HA-DOTATATE PET/CT or PET/MRI and baseline CT/MRI will be made.
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: NET Coordinator||780-577-8080||ACB.NeuroEndocrine@ahs.ca|
|Cross Cancer Institute|
|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|
|Principal Investigator:||Todd PW McMullen, MD, PhD, FRCSC, FACS||Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology|