Clinical trial NCT04090034: Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
Official title: Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neuroendocrine Tumors
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2019-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be screened for NETs per standard of care. Those patients, who have or will undergo the PRRT procedure, will be offered the opportunity to participate in this registry study.

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Demographics and other patient data
timeFrame: 7 years from date of procedure
measure: Tumor specific data
timeFrame: 7 years from date of procedure
measure: Use of somatostatin analogs
timeFrame: 7 years from date of procedure
measure: Biomarker data (chromogranin A and pancreastatin)
timeFrame: 7 years from date of procedure
measure: Diagnostic imaging findings
timeFrame: 7 years from date of procedure
measure: Overall survival (OS)
timeFrame: 7 years from date of procedure
measure: Time to progression (TTP)
timeFrame: 7 years from date of procedure
measure: Treatment responses and progression
timeFrame: 7 years from date of procedure
measure: Response
timeFrame: 7 years from date of procedure
measure: Disease progression
timeFrame: 7 years from date of procedure
measure: Adverse events
timeFrame: 7 years from date of procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Clinical Research Institute at Methodist Health System
state: Texas
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Liver Institute at Methodist Dallas Medical Center
name: Alejandro Mejia, MD
role: PRINCIPAL_INVESTIGATOR
References: