Clinical trial NCT03145857: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Neuroendocrine Tumors
Keywords: Gallium-68
Positron Emission Tomography
68Ga-HA-DOTATATE
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 1534
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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 obtained within 6 months of enrolment is required. A standard MRI obtained within 6 months of enrolment is optional. 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.

Primary outcomes:
measure: Change in vital signs after first [68]Ga-HA-DOTATATE injection (safety sub-group)
timeFrame: Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min)
measure: Changes in haematology and biochemistry after first [68]Ga-HA-DOTATATE injection (safety sub-group)
timeFrame: Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min)
measure: Number of participants with adverse events within 24 hours (safety sub-group)
timeFrame: Within 24 hours of [68]Ga-HA-DOTATATE scan completion
measure: Number of participants with adverse events
timeFrame: Up to 2 hours after [68]Ga-HA-DOTATATE administration
measure: Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care CT
timeFrame: Up to 6 years
Secondary outcomes:
measure: Evaluation of [68]Ga-HA-DOTATATE scan changes compared to baseline scan
timeFrame: Up to 6 years
measure: Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care MRI
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: Associate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology
name: Todd PW McMullen, MD, PhD, FRCSC, FACS
role: PRINCIPAL_INVESTIGATOR
References: