Preoperative PRRT Versus Surgical Cytoreduction in Metastatic Pancreatic Neuroendocrine Tumors to the Liver

• Status: Not yet recruiting
• Trial end date: 2027-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Chicago
• Treatments: Lutetium Lu 177 dotatate

Criteria

Inclusion Criteria:

• Metastatic Pancreatic neuroendocrine tumors (PanNET) to the liver

• Well- or moderately differentiated (grade 1 or grade 2, Ki-

• Ability to aim for equal or greater than 90% hepatic cytoreduction surgically

• Proof of SSTR2 expression by uptake of tumor on 68Ga DOTATATE PET CT (Krenning Score on all or a majority of lesions

• Age older than 18 years

• No history of chemotherapy for 4 weeks prior to enrollment (both patients with stable disease as well as those with tumor progression under other therapies will be enrolled).

Exclusion Criteria:

• Patient with G3 or poorly differentiated NET (grade 3, Ki-67 >20%)

• Previous liver-directed therapy with Yttrium-90/TACE/TAE

• Previous systemic therapy with Capecitabine and/or Temozolomide

• No tumor uptake on 68Ga DOTATATE PET CT

• Liver tumor burden > 50% (as defined by CT or MRI)

• Signs of early liver failure (T-Bilirubin >3, INR > 1.5, Albumin <3.0 g/dL unless prothrombin time is within the normal range) or cirrhosis or ascites

• calculated by the Cockroft Gault method, eventually confirmed by measured creatinine clearance

• (or measured glomerular filtration rate (GFR) using plasma clearance methods, not gamma

• camera-based) <50 mL/min (the measured creatinine clearance / GFR is required only as
• confirmatory exam).

• 2. Hb concentration <5.0 mmol/L (<8.0 g/dL); WBC <2x109/L (2000/mm3); platelets <75x109/L - (75x103/mm3).

• Known brain metastases, unless these metastases have been treated and stabilized.

• Uncontrolled congestive heart failure (NYHA II, III, IV).

• Uncontrolled diabetes mellitus as defined by a fasting blood glucose >2 ULN.

• Pregnancy or lactation.

• For female patients of childbearing potential (defined as < 2 years after last menstruation and not surgically sterile) and male patients, who are not surgically sterile or with female partners of childbearing potential: absence of effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal gel). - Prior external beam radiation therapy to more than 25% of the bone marrow.

• Current spontaneous urinary incontinence making impossible the safe administration of the radioactive IMP.

• Other known co-existing malignancies except non-melanoma skin cancer and carcinoma in situ of the uterine cervix, unless definitively treated and with no evidence of recurrence.

• Patients who have not provided a signed informed consent form to accept this treatment.

• Poor renal function