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

Launched by METHODIST HEALTH SYSTEM · Sep 12, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Peptide Receptor Radionuclide Therapy (PRRT) for patients with neuroendocrine tumors (NETs) that originate in the gastroenteropancreatic area, which includes the pancreas and digestive system. The goal is to understand how well this treatment works, how it affects patients' survival, and what side effects may occur. Researchers are looking for participants aged 18 and older who have been diagnosed with this type of tumor and who are not candidates for surgery. Participants should also have shown disease progression while on another treatment called Octreotide.

If you join this trial, you’ll receive PRRT, and the medical team will closely monitor your health and how your body responds to the treatment. To be eligible, you need to meet certain health requirements, such as having specific blood test results and being willing to follow the study guidelines. The trial is currently recruiting participants, and it’s important that you can understand and sign the consent form in English. This study aims to provide valuable information that could improve future treatments for neuroendocrine tumors.

Gender

ALL

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