What is the mechanism of action of this treatment?

Common treatments for Neuroendocrine Tumors (NETs) often target somatostatin receptors, similar to the [68]Ga-HA-DOTATATE used for tumor visualization. Somatostatin analogs, such as octreotide and lanreotide, bind to these receptors to inhibit hormone secretion and slow tumor growth. Peptide receptor radionuclide therapy (PRRT), like Lutetium Lu-177 dotatate, uses radiolabeled somatostatin analogs to deliver targeted radiation to NET cells, leading to cell death. These targeted treatments are essential for NET patients as they offer effective control of tumor growth and symptom management.

What side effects are associated with this type of intervention?

Common treatments for neuroendocrine tumors that target somatostatin receptors, such as 177Lu-Dotatate, are generally well-tolerated but can have side effects. These include nausea, mild hematologic toxicities like thrombocytopenia, lymphopenia, anemia, and leukopenia, which typically resolve within weeks. Serious adverse events are rare but can include myelodysplastic syndrome, acute myeloid leukemia, and nephrotoxicity, particularly in patients with pre-existing kidney issues. Overall, these treatments are effective but require careful monitoring for potential toxicities.

What prior FDA approvals exist?

The FDA has approved several treatments for neuroendocrine tumors (NETs) that target somatostatin receptors. One notable approval is for 177Lu-Dotatate (Lutathera), a peptide receptor radionuclide therapy (PRRT) that binds to somatostatin receptors on NET cells, delivering targeted radiation. This treatment was approved in January 2018 for gastroenteropancreatic NETs. Another related drug is Octreotide (Sandostatin), a somatostatin analog used to control symptoms and inhibit tumor growth in NET patients. These treatments, like [68]Ga-HA-DOTATATE, leverage the presence of somatostatin receptors on NETs for targeted therapy and diagnostic imaging.

What other types of research exist?

Promising alternatives to [68]Ga-HA-DOTATATE for neuroendocrine tumor patients include [18F]FDOPA, [11C]/[18F]-HTP, 177Lu-DOTATATE, 90Y-DOTATOC, and 212Pb-DOTAMTATE. These alternatives target somatostatin receptors or have shown efficacy in NETs, providing options for both imaging and therapeutic purposes.

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[68]Ga-HA-DOTATATE Imaging for Neuroendocrine Tumors

Phase 1 & 2

Recruiting

Led By Todd PW McMullen, MD, PhD, FRCSC, FACS

Research Sponsored by AHS Cancer Control Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 14 years of age

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

Must not have

Allergic reaction to DOTATATE or somatostatin analogues

Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests a new type of body scan for patients with certain types of tumors. The scan uses a small amount of radioactive material to highlight tumors by sticking to specific spots on them. It aims to show that this method is safe and more accurate than current scans. The new scan is useful for locating primary tumors in patients with certain types of cancer.

Who is the study for?

This trial is for individuals at least 14 years old with suspected or known tumors that have somatostatin receptors, such as various types of neuroendocrine tumors. Participants must be able to follow the study's protocol and have an ECOG score ≤ 3, indicating they are capable of self-care. They cannot join if they exceed the weight limit for PET scans, are pregnant, allergic to DOTATATE/somatostatin analogues, or unable to remain still during imaging.

What is being tested?

[68]Ga-HA-DOTATATE is being tested in this trial. It's a new diagnostic agent used in PET/CT or PET/MRI scans to detect somatostatin receptors on tumors more accurately than current methods like Octreoscan™. The study aims to ensure it's safe and effective for identifying these types of tumors.

What are the potential side effects?

While the main focus is on safety and effectiveness rather than side effects, potential risks may include reactions similar to those from other contrast agents used in imaging studies: mild pain or discomfort at injection site, nausea, itching or rash.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 14 years old or older.

Select...

My tumor is suspected to be positive for somatostatin receptors.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am allergic to DOTATATE or similar drugs.

Select...

I cannot stay still for long periods due to a condition like severe arthritis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in vital signs after first [68]Ga-HA-DOTATATE injection (safety sub-group)

Changes in haematology and biochemistry after first [68]Ga-HA-DOTATATE injection (safety sub-group)

Correlation of [68]Ga-HA-DOTATATE scan diagnostic effectiveness with standard of care CT or MRI

+2 more

Secondary study objectives

Evaluation of [68]Ga-HA-DOTATATE scan changes compared to baseline scan

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: [68]Ga-HA-DOTATATEExperimental Treatment1 Intervention

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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Neuroendocrine Tumors (NETs) often target somatostatin receptors, similar to the [68]Ga-HA-DOTATATE used for tumor visualization. Somatostatin analogs, such as octreotide and lanreotide, bind to these receptors to inhibit hormone secretion and slow tumor growth. Peptide receptor radionuclide therapy (PRRT), like Lutetium Lu-177 dotatate, uses radiolabeled somatostatin analogs to deliver targeted radiation to NET cells, leading to cell death. These targeted treatments are essential for NET patients as they offer effective control of tumor growth and symptom management.

In- and Y-DOTA-lanreotide: results and implications of the MAURITIUS trial.

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Who is running the clinical trial?

AHS Cancer Control AlbertaLead Sponsor

182 Previous Clinical Trials

26,214 Total Patients Enrolled

2 Trials studying Neuroendocrine Tumors

207 Patients Enrolled for Neuroendocrine Tumors

Todd PW McMullen, MD, PhD, FRCSC, FACSPrincipal InvestigatorAssociate Professor of Surgery and Oncology; Director, Division of Surgical Oncology, Department of Oncology