NCT04090034 · Methodist Health System
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
(PRRT)
What this study is about
The specific aim is of this study is to gain a better understanding of the patient characteristics, treatment responses, survival outcomes, and side effects associated with PRRT in patients with gastroenteropancreatic primary NETs.
View original scientific description
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.
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
(such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis)
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)
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
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
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
Overall survival (OS)
Time frame: 7 years from date of procedure
the time from diagnosis to death of any cause.
Time to progression (TTP)
Time frame: 7 years from date of procedure
the time from the first PRRT until any progression on diagnostic imaging
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).
Response
Time frame: 7 years from date of procedure
any response of any magnitude
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- 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
Where
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 20, 2026 · Source of record for eligibility and locations