NCT04090034 Peptide Receptor Radionuclide Therapy (PRRT) for the Treatment of Neuroendocrine Tumors
| NCT ID | NCT04090034 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Methodist Health System |
| Condition | Neuroendocrine Tumors |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-03-28 |
| Primary Completion | 2026-06-28 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-03-28 with a primary completion date of 2026-06-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Alejandro Mejia, MD
PRINCIPAL INVESTIGATOR
Liver Institute at Methodist Dallas Medical Center
Frequently Asked Questions
Who can join the NCT04090034 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuroendocrine Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04090034 currently recruiting?
Yes, NCT04090034 is actively recruiting participants. Contact the research team at clinicalresearch@mhd.com for enrollment information.
Where is the NCT04090034 trial being conducted?
This trial is being conducted at Dallas, United States, Dallas, United States.
Who is sponsoring the NCT04090034 clinical trial?
NCT04090034 is sponsored by Methodist Health System. The principal investigator is Alejandro Mejia, MD at Liver Institute at Methodist Dallas Medical Center. The trial plans to enroll 50 participants.