Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers
No
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 Somatostatin Analogues (SSA) or other systemic therapy for 4 weeks prior to
starting PRRT, if randomized to arm 2.
Exclusion Criteria:
- Patient with G3 or poorly differentiated NET (grade 3, Ki-67 >20%)
- Previous liver-directed therapy with Yttrium-90 (TACE/TAE allowed if performed more
than 12 months prior to enrollment)
- Systemic therapy with Capecitabine and/or Temozolamide within 12 months of
enrollment.
- 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
- Quality Unit language added
- editorial changes
