Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peptide Receptor Radionuclide Therapy.
- Who it may be relevant to
- Registry conditions: Neuroendocrine Tumors, Gastroenteropancreatic Neuroendocrine Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine
Overview
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.
Detailed 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.
Interventions
- Procedure Peptide Receptor Radionuclide Therapy
a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs
Primary outcome measures
- Demographics and other patient data [Time frame: 7 years from date of procedure]
- Tumor specific data [Time frame: 7 years from date of procedure]
- Use of somatostatin analogs [Time frame: 7 years from date of procedure]
- Biomarker data (chromogranin A and pancreastatin) [Time frame: 7 years from date of procedure]
- Diagnostic imaging findings [Time frame: 7 years from date of procedure]
- Overall survival (OS) [Time frame: 7 years from date of procedure]
- Time to progression (TTP) [Time frame: 7 years from date of procedure]
- Treatment responses and progression [Time frame: 7 years from date of procedure]
- Response [Time frame: 7 years from date of procedure]
- Disease progression [Time frame: 7 years from date of procedure]
Eligibility criteria
Inclusion criteria
- > 18 years of age
- 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.
- Willing and able to comply with the protocol requirements
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Clinical Research Institute at Methodist Health System — Dallas
- Methodist Dallas Medical Center — Dallas
Identifiers
NCT: NCT04090034 · 022.HPB.2019.D