Preoperative PRRT Versus Surgical Cytoreduction in Metastatic Pancreatic Neuroendocrine Tumors to the Liver
NCT05610826 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL
Last updated 2024-10-26
Summary
Doctors and researchers leading this study hope to learn more about peptide receptor radionuclide therapy (PRRT) in combination with cytoreduction (surgically removing tumors). They hope to learn if combining PRRT in combination with cytoreduction would be more effective than cytoreduction alone. PRRT itself is approved by the U.S. Food and Drug Administration (FDA) for people with PanNETs however the combination with cytoreduction is considered experimental.
Your participation in this research will last about 2 years. The purpose of this research is to gather information on the safety and effectiveness of PRRT.
Conditions
- Pancreatic Neuroendocrine Tumor
- Pancreas Cancer
Interventions
- PROCEDURE
-
cytoreductive surgery
Cytoreductive surgery is an operation to remove as much tumor tissue as possible.
- DRUG
-
Lutathera - a small molecule used in Peptide Receptor Radionuclide Therapy (PRRT)
PRRT is a form of targeted treatment (think of a "lock and key") done by the use of a small molecule (Lutathera). Lutathera acts as a "key" to "lock" onto certain areas your tumor cells called receptors when injected into a vein and travels through blood.
- PROCEDURE
-
Peptide receptor radionuclide therapy (PRRT)
PRRT is a molecular targeted therapy used to treat neuroendocrine tumors (NET). Molecular targeted therapies use drugs or other substances to identify and attack cancer cells while reducing harm to healthy tissue. PRRT delivers high doses of radiation to tumors in the body to destroy or slow their growth and reduce disease side effects.
Sponsors & Collaborators
-
University of Chicago
lead OTHER
Principal Investigators
-
Xavier Keutgen, MD · University of Chicago
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-03-07
- Primary Completion
- 2024-09-11
- Completion
- 2024-09-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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