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Observational Study of Peptide Receptor Radionuclide Therapy (PRRT) for Neuroendocrine Tumors

This study is looking at how Peptide Receptor Radionuclide Therapy (PRRT), a type of molecular therapy, works for people with neuroendocrine tumors (NETs), specifically those that start in the digestive system (gastroenteropancreatic primary NETs). Researchers want to understand patient characteristics, how well PRRT treats the tumors, how long people live, and any side effects. You might be able to join if you are over 18, have a gastroenteropancreatic primary NET that is advanced or inoperable, and have agreed to receive PRRT. The study will collect information about your health and tumor for up to 7 years after your PRRT procedure to learn more about this treatment.

Study design
This is an observational study, meaning researchers will collect information from about 50 participants who are already receiving PRRT. It is not a randomized study.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 7 years from the date of their PRRT procedure to collect data on their health and tumor.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04090034

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

Recruiting
Not specifiedAges 18+Observational
Methodist Health System
~50 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Peptide Receptor Radionuclide Therapy

At a glance

Recruiting sites
1 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Demographics and other patient data
Measured over 7 years from date of procedure
+10 more outcomes measured

Conditions

Neuroendocrine Tumors
Gastroenteropancreatic Neuroendocrine Tumor

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Digestive System Neuroendocrine TumorNeuroendocrine NeoplasmMKI67 GeneSomatostatin Receptor

Where it's being run

2 sites across 1 states
Texas2

Study leadership

  • Alejandro Mejia, MD · PRINCIPAL_INVESTIGATOR · Liver Institute at Methodist Dallas Medical Center

Who to contact

Colette N Ndjom, MS
[email protected]
214-947-1280
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Demographics and other patient data7 years from date of procedure

    (such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis)

  • Tumor specific data7 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)

  • Use of somatostatin analogs7 years from date of procedure

    at the time of PRRT, location, isotope used and dose of isotope for each PRRT

  • Biomarker data (chromogranin A and pancreastatin)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

  • Diagnostic imaging findings7 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

  • Overall survival (OS)7 years from date of procedure

    the time from diagnosis to death of any cause.

  • Time to progression (TTP)7 years from date of procedure

    the time from the first PRRT until any progression on diagnostic imaging

  • Treatment responses and progression7 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).

  • Response7 years from date of procedure

    any response of any magnitude

  • Disease progression7 years from date of procedure

    any increase in lesion sizes and/or appearance of new metastatic lesions on diagnostic imaging exams.

  • Adverse events7 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.