What side effects are associated with this type of intervention?

Common treatments for Neuroendocrine Tumors (NETs) include somatostatin analogs like octreotide, peptide receptor radionuclide therapy (PRRT) with 177Lu-Dotatate, and molecular targeted therapies such as everolimus. Octreotide can cause side effects like nausea, diarrhea, and abdominal pain. PRRT with 177Lu-Dotatate is generally well-tolerated but can lead to nausea, mild hematologic toxicities (e.g., thrombocytopenia, lymphopenia, anemia), and, rarely, myelodysplastic syndrome. Everolimus may cause stomatitis, rash, diarrhea, fatigue, and hyperglycemia. These treatments aim to control tumor growth and manage symptoms but come with varying side effect profiles.

What prior FDA approvals exist?

The FDA has approved several treatments for Neuroendocrine Tumors (NETs) that are related to somatostatin receptor imaging and therapy. Notably, 177Lu-Dotatate (Lutathera) was approved in January 2018 for the treatment of somatostatin-receptor-positive gastroenteropancreatic NETs in adults, based on the NETTER-1 trial. This therapy involves Peptide Receptor Radionuclide Therapy (PRRT) and has shown significant improvement in progression-free survival. Additionally, long-acting somatostatin analogs such as octreotide (Sandostatin LAR) and lanreotide (Somatuline Depot) are approved for inhibiting tumor growth and controlling symptoms in patients with somatostatin receptor-expressing tumors.

What other types of research exist?

Promising alternatives to 68Ga-HA-DOTATATE for SSR PET imaging in NET patients include 177Lu-DOTATATE, which has shown higher progression-free survival and objective response rates compared to octreotide LAR. Additionally, iobenguane I-131 has demonstrated biochemical and radiographic responses in some patients with gastroenteropancreatic NETs. Molecularly targeted therapies like everolimus are also suggested for patients with progressive NETs, especially those not suitable for peptide receptor radionuclide therapy.

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68Ga-HA-DOTATATE Imaging for Neuroendocrine Tumors

Phase 2

Recruiting

Led By Jonathan Abele, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

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

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-scan

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new imaging scan for patients with specific types of tumors. The scan uses a special substance to make the tumors more visible. It aims to provide better images for accurate diagnosis and monitoring.

Who is the study for?

This trial is for patients with suspected or confirmed somatostatin receptor positive tumors, such as certain neuroendocrine tumors. Participants must have had a CT or MRI within the last 6 months and be able to consent. It's not for those who've had allergic reactions to DOTATATE, weigh over 225 kg, can't lie still for imaging due to conditions like extreme claustrophobia, or lack intravenous access.

What is being tested?

The study tests the safety and diagnostic effectiveness of a new imaging agent called 68Ga-HA-DOTATATE in detecting somatostatin receptor positive tumors using PET scans. This could potentially offer better image quality and accuracy compared to older methods.

What are the potential side effects?

While specific side effects are not listed, potential risks may include allergic reactions similar to previous allergies to DOTATATE or related compounds. The procedure involves lying still during PET scanning which might cause discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-scan

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post-scan

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-scan for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Efficacy - sensitivity

Efficacy - specificity

Secondary study objectives

Safety - adverse events - delayed

Safety - adverse events - immediate

Safety - adverse events - post-scan

Awards & Highlights

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: 68Ga-HA-DOTATATE PET/CT scanExperimental Treatment1 Intervention

2.64 MBq/kg (minimum 37 MBq, maximum 250 MBq) 68Ga-HA-DOTATATE intravenous single-dose administration for PET/CT imaging

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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

The most common treatments for Neuroendocrine Tumors (NETs) include somatostatin analogs, peptide receptor radionuclide therapy (PRRT), and molecular targeted therapies. Somatostatin analogs, such as octreotide and lanreotide, bind to somatostatin receptors on tumor cells, inhibiting hormone secretion and tumor growth. PRRT, like 177Lu-DOTATATE, combines a radioactive isotope with a somatostatin analog to deliver targeted radiation to the tumor cells, effectively killing them. Molecular targeted therapies, such as everolimus, inhibit pathways essential for tumor cell growth and survival. These targeted treatments are crucial for NET patients as they help manage symptoms, control tumor progression, and improve overall quality of life.

Advances and Current Concepts in the Medical Management of Gastroenteropancreatic Neuroendocrine Neoplasms.