Health TrialsbyHealthPanel

68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors

ConditionNeuroendocrine Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity of Alberta

About this trial

Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumors. In the past, 111In-octreotide imaging has been used for this purpose but it has been recently supplanted globally by SSR positron emission tomography (PET) imaging due to better image quality and higher diagnostic accuracy.

This study will assess the safety and diagnostic effectiveness of 68Ga-HA-DOTATATE produced a the Edmonton Radiopharmaceutical Centre (ERC).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma

A standard clinical CT or MRI is obtained within 6 months of enrollment

Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker)

Disqualifiers

Weight > 225 kg (weight limit of the PET/CT scanner)

Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging

Any additional medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation

Previous allergic reaction to DOTATATE or somatostatin analogues

Trial design

Design model

Single group

Treatments tested in this trial

  • 68Ga-HA-DOTATATE

    Drug

    Tracer injection

Treatment groups

600 Participants
are divided into 1 treatment group
Group A: 68Ga-HA-DOTATATE PET/CT scanExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Efficacy - sensitivity

Sensitivity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up

Time frame
1 year post-scan
2

Efficacy - specificity

Specificity of 68Ga-HA-DOTATATE PET/CT compared to 1 year clinical follow-up

Time frame
1 year post-scan

Secondary outcomes

1

Safety - adverse events - immediate

Assessment of adverse events immediately after tracer injection

Time frame
Immediately (within 15 minutes) after tracer injection
2

Safety - adverse events - post-scan

Assessment of adverse events immediately after PET/CT scan

Time frame
Immediately (within 15 minutes) after PET/CT scan; 60 to 100 minutes after tracer injection
3

Safety - adverse events - delayed

Self-reporting of possible adverse events after leaving the PET department

Time frame
10 days after tracer injection

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Source ClinicalTrials.gov
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