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Trial record 1 of 50 for:    Peptide Receptor | Neuroendocrine Tumors
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Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors (PRRT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04090034
Recruitment Status : Enrolling by invitation
First Posted : September 16, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Methodist Health System

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.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Procedure: Peptide Receptor Radionuclide Therapy

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine
Actual Study Start Date : June 28, 2019
Estimated Primary Completion Date : June 2026
Estimated Study Completion Date : June 2028

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Treated w PRRT
Patients who received treatment of gastroenteropancreatic primary NETs with PRRT per the treating physicians discretion.
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 :
  1. Demographics and other patient data [ Time Frame: 7 years from date of procedure ]
    (such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis)

  2. Tumor specific data [ Time Frame: 7 years from date of procedure ]
    Tumor site, tumor grade, stage, presence of tumor necrosis, number of mitoses and percentage of Ki-67 and MIB-1 positive cells (proliferative index)

  3. Use of somatostatin analogs [ Time Frame: 7 years from date of procedure ]
    at the time of PRRT, location, isotope used and dose of isotope for each PRRT

  4. Biomarker data (chromogranin A and pancreastatin) [ Time Frame: 7 years from date of procedure ]
    at the time of diagnosis, before and after the first PRRT, and after the second PRRT were also extracted

  5. Diagnostic imaging findings [ Time Frame: 7 years from date of procedure ]
    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

  6. Overall survival (OS) [ Time Frame: 7 years from date of procedure ]
    the time from diagnosis to death of any cause.

  7. Time to progression (TTP) [ Time Frame: 7 years from date of procedure ]
    the time from the first PRRT until any progression on diagnostic imaging

  8. Treatment responses and progression [ Time Frame: 7 years from date of procedure ]
    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).

  9. Response [ Time Frame: 7 years from date of procedure ]
    any response of any magnitude

  10. Disease progression [ Time Frame: 7 years from date of procedure ]
    any increase in lesion sizes and/or appearance of new metastatic lesions on diagnostic imaging exams.

  11. Adverse events [ Time Frame: 7 years from date of procedure ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090034


Locations
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United States, Texas
Methodist Health System
Dallas, Texas, United States, 75203
Sponsors and Collaborators
Methodist Health System
Investigators
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Principal Investigator: Alejandro Mejia, MD Liver Institute at Methodist Dallas Medical Center

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Responsible Party: Methodist Health System
ClinicalTrials.gov Identifier: NCT04090034    
Other Study ID Numbers: 022.HPB.2019.D
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue