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

Neuroendocrine Tumors Clinical Trial

— PRRT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04090034
• Other study ID #: 022.HPB.2019.D
• Status: Recruiting
• Start date: March 28, 2024
• Est. completion date: June 28, 2024

Study information

• Verified date: March 2023
• Source: Methodist Health System
• Contact: Colette N Ndjom, MS
• Phone: 214-947-1280
• Email: MHSIRB[@]mhd.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 28, 2024
• Est. primary completion date: June 28, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuroendocrine Tumors

Intervention

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

Locations

Country	Name	City	State
United States	Clinical Research Institute at Methodist Health System	Dallas	Texas
United States	Methodist Dallas Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Methodist Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics and other patient data	(such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis)	7 years from date of procedure
Primary	Tumor specific data	Tumor site, tumor grade, stage, presence of tumor necrosis, number of mitoses and percentage of Ki-67 and MIB-1 positive cells (proliferative index)	7 years from date of procedure
Primary	Use of somatostatin analogs	at the time of PRRT, location, isotope used and dose of isotope for each PRRT	7 years from date of procedure
Primary	Biomarker data (chromogranin A and pancreastatin)	at the time of diagnosis, before and after the first PRRT, and after the second PRRT were also extracted	7 years from date of procedure
Primary	Diagnostic imaging findings	prior to PRRT and response after PRRT, date of progression on imaging after PRRT, and status of disease on imaging at the last follow-up were also recorded	7 years from date of procedure
Primary	Overall survival (OS)	the time from diagnosis to death of any cause.	7 years from date of procedure
Primary	Time to progression (TTP)	the time from the first PRRT until any progression on diagnostic imaging	7 years from date of procedure
Primary	Treatment responses and progression	assessed with cross-sectional imaging with either computerized tomography (CT) or magnetic resonance imaging (MRI) or positron emission tomography (PET) or single-photon emission computed tomography (SPECT).	7 years from date of procedure
Primary	Response	any response of any magnitude	7 years from date of procedure
Primary	Disease progression	any increase in lesion sizes and/or appearance of new metastatic lesions on diagnostic imaging exams.	7 years from date of procedure
Primary	Adverse events	will be assessed by the investigator who will determine whether or not the event is related to PRRT or related to progression of disease (gastroenteropancreatic primary NET), and whether or not the event meets serious criteria. AEs related to PRRT will be recorded in the study registry.	7 years from date of procedure