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

Overview

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.

Interventions

• Drug [68]Ga-HA-DOTATATE
  All participants will be injected with \[68\]Ga-HA-DOTATATE approximately 60 minutes before PET/CT or PET/MRI scan.

Primary outcome measures

• Change in vital signs after first [68]Ga-HA-DOTATATE injection (safety sub-group) [Time frame: Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min)]
• Changes in haematology and biochemistry after first [68]Ga-HA-DOTATATE injection (safety sub-group) [Time frame: Before first [68]Ga-HA-DOTATATE injection and after [68]Ga-HA-DOTATATE scan (within ~30 min)]
• Number of participants with adverse events within 24 hours (safety sub-group) [Time frame: Within 24 hours of [68]Ga-HA-DOTATATE scan completion]
• Number of participants with adverse events [Time frame: Up to 2 hours after [68]Ga-HA-DOTATATE administration]
• Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care CT [Time frame: Up to 6 years]

Secondary outcome measures (2)

• Evaluation of [68]Ga-HA-DOTATATE scan changes compared to baseline scan [Time frame: Up to 6 years]
• Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care MRI [Time frame: Up to 6 years]

Eligibility criteria

Inclusion criteria

• 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;
• 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.

Exclusion criteria

• 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;
• Pregnancy;
• Allergic reaction to DOTATATE or somatostatin analogues.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Canada · 1 center

• Cross Cancer Institute — Edmonton

Identifiers

NCT: NCT03145857 · DX-GAL-001 · HREBA.CC-16-1013

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗