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 : Recruiting
First Posted : May 9, 2017
Last Update Posted : January 18, 2023
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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|
|Actual Study Start Date :||March 5, 2020|
|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.
- Evaluation of Ga-HA-DOTATATE scan changes compared to baseline scan [ Time Frame: Up to 6 years ]As applicable, follow-up Ga-HA-DOTATATE scans will be evaluated for abnormal accumulation of 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 Ga-HA-DOTATATE. An overall assessment of the correlation between the follow-up and baseline scan will be made.
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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|
- 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), F-FDG PET, or 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.
- 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;
- Allergic reaction to DOTATATE or somatostatin analogues.
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||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|
|Principal Investigator:||Todd PW McMullen, MD, PhD, FRCSC, FACS||Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology|
|Responsible Party:||AHS Cancer Control Alberta|
|Other Study ID Numbers:||
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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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