Neuroendocrine TumorsPRRTNCT04090034
Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
An observational study of Neuroendocrine Tumors and Gastroenteropancreatic Neuroendocrine Tumor, run by Methodist Health System at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Gastroenteropancreatic Neuroendocrine Tumor
- What is being tested?
- Peptide Receptor Radionuclide Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Mar 2024to 28 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- > 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
Show all 16Show fewer
- 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.
- Willing and able to comply with the protocol requirements
- Able to comprehend and sign the Informed Consent Form in English.
Who cannot join
- Do not meet the Study Inclusion Criteria laid out in section 6.3
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Clinical Research Institute at Methodist Health System
Dallas, Texas, 75203
Colette N Ndjom, MS, 410-947-4681 ext. 74681, ColetteNgoNdjom@mhd.com
Loretta W Bedell, MPH, 214-947-4680 ext. 74680, lorettabedell@mhd.com
- Enrolling by invitation
Methodist Dallas Medical Center
Dallas, Texas, 75203
About this study
Official title: Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine
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.
Read the 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.
- Being tested
- Peptide Receptor Radionuclide Therapy
- Medical subject headings
- Neuroendocrine Tumors, Gastro-enteropancreatic neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peptide Receptor Radionuclide TherapyProcedure or surgery
a molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs
| Study group | Role | What they receive |
|---|---|---|
| Treated w PRRT | Patients who received treatment of gastroenteropancreatic primary NETs with PRRT per the treating physicians discretion. Receives: Procedure: Peptide Receptor Radionuclide Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics and other patient data
(such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis)
Measured: 7 years from date of procedure
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)
Measured: 7 years from date of procedure
Use of somatostatin analogs
at the time of PRRT, location, isotope used and dose of isotope for each PRRT
Measured: 7 years from date of procedure
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
Measured: 7 years from date of procedure
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
Measured: 7 years from date of procedure
Overall survival (OS)
the time from diagnosis to death of any cause.
Measured: 7 years from date of procedure
Time to progression (TTP)
the time from the first PRRT until any progression on diagnostic imaging
Measured: 7 years from date of procedure
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).
Measured: 7 years from date of procedure
Response
any response of any magnitude
Measured: 7 years from date of procedure
Disease progression
any increase in lesion sizes and/or appearance of new metastatic lesions on diagnostic imaging exams.
Measured: 7 years from date of procedure
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.
Measured: 7 years from date of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start28 Mar 2024
- Primary completion28 Jun 2026 (estimated)
- Study completion28 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Methodist Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alejandro Mejia, MD, Principal investigator, Liver Institute at Methodist Dallas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090034
- Sponsor's protocol ID
- 022.HPB.2019.D
- Acronym
- PRRT
- Status last verified
- Mar 2026
- First submitted
- 12 Sep 2019
- Last updated
- 20 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine
- ClinicalTrials.gov ID
- NCT04090034
- Acronym / sponsor ID
- PRRT / 022.HPB.2019.D
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Methodist Health SystemUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 28 Jun 2026 (estimated)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated w PRRT | – | Procedure: Peptide Receptor Radionuclide TherapyPatients who received treatment of gastroenteropancreatic primary NETs with PRRT per the treating physicians discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (16 listed)
- > 18 years of age
- Diagnosed with gastroenteropancreatic primary NET and has consented to undergo PRRT per the treating physician. Specifically:
- Willing and able to comply with the protocol requirements
- Able to comprehend and sign the Informed Consent Form in English.
Key exclusion criteria (1 listed)
- Do not meet the Study Inclusion Criteria laid out in section 6.3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peptide Receptor Radionuclide Therapya molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs | Procedure or surgery | Treated w PRRT |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alejandro Mejia, MD principal investigator
Liver Institute at Methodist Dallas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors and Gastroenteropancreatic Neuroendocrine Tumor, run by Methodist Health System at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Colette N Ndjom, MS (214-947-1280, clinicalresearch@mhd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics and other patient data (time frame: 7 years from date of procedure). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.