Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors

Methodist Health System

Status: Enrolling

Conditions: Neuroendocrine Tumors

Treatments: Procedure: Peptide Receptor Radionuclide Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT04090034

022.HPB.2019.D

Details and patient eligibility

About

The specific aim is of this study is to gain a better understanding of the patient characteristics, treatment responses, survival outcomes, and adverse events associated with PRRT in patients with gastroenteropancreatic primary NETs.

Full description

Neuroendocrine tumors (NETs) make up a large range of malignancies that arise from neuroendocrine cells in multiple organs of the body. Hallet et al conducted a large population-based study that demonstrated that 21% of NET patients presented with metastatic disease and another 38% developed metastases after resection of the primary tumor (Hallet et al., 2015). This burden demonstrates the need for effective systemic therapy for advanced NETs. Options for systemic therapy include peptide receptor radionuclide therapy (PRRT).

A need for more prospective series are needed on treatment responses and survival outcomes related to gastroenteropancreatic primary NETs treated with PRRT was identified. Thus the purpose of this study is to collect clinical data related to treatment of gastroenteropancreatic primary NETs s with PRRT. Clinical data related to patient characteristics, treatment responses and survival outcomes related to the treatment of gastroenteropancreatic primary NETs with PRRT and on adverse events and complications related to PRRT treatment will be collected.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. > 18 years of age

2. Diagnosed with gastroenteropancreatic primary NET and has consented to undergo PRRT per the treating physician. Specifically:

   • Will consider other primaries on a case by case basis if dotatate scan (+) and meet all other criteria.

   • Metastatic or Locally Advanced AND Inoperable

   • Clear disease progression on Octreotide over less than 3 years (RECIST 1.1)

   • Presence of disease within 24 weeks as identified by PET/CT scans with Ga-68 DOTATATE reporting the Krenning score for low-grade NET and/or PET/CT scans with FDG for transformation to high-grade NET

   • Well differentiated on path - Ki67 < 20%

   • Octreotide positive on pathology (if not documented, acceptable if PET/CT imaging shows lesions with Ga-68 DOTATATE uptakeLabs:

     • Cr. <1.7
     • Hgb >8
     • WBC >2K
     • Plt >75K
     • Bili < 3x normal limit

   • No Octreotide within 30 days of administration.

3. Willing and able to comply with the protocol requirements

4. Able to comprehend and sign the Informed Consent Form in English.

Exclusion criteria

• Do not meet the Study Inclusion Criteria laid out in section 6.3

Trial design

50 participants in 1 patient group

Treated w PRRT

Description:

Patients who received treatment of gastroenteropancreatic primary NETs with PRRT per the treating physicians discretion.

Treatment:

Procedure: Peptide Receptor Radionuclide Therapy