Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMethodist Health System
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
> 18 years of age
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)
Disqualifiers
Do not meet the Study Inclusion Criteria laid out in section 6.3
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Peptide Receptor Radionuclide Therapy
Procedure/Surgerya molecular therapy (also called radioisotope therapy) used to treat a specific type of cancer called neuroendocrine tumors or NETs
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Treated w PRRT1 intervention
Trial outcomes
Primary outcomes
1
Demographics and other patient data
(such as age at diagnosis, sex, history of smoking alcohol use and symptoms at the time of diagnosis)
Time frame
7 years from date of procedure2
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)
Time frame
7 years from date of procedure3
Use of somatostatin analogs
at the time of PRRT, location, isotope used and dose of isotope for each PRRT
Time frame
7 years from date of procedure4
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
Time frame
7 years from date of procedureSponsors and contacts
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Source ClinicalTrials.gov