Status:
COMPLETED
177Lutetium-octreotate Treatment Prediction Using Multimodality Imaging in Refractory NETs
Lead Sponsor:
Jules Bordet Institute
Conditions:
Gastroenteropancreatic Neuroendocrine Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if 68Gallium-octreotate and 18Fluorodesoxyglucose uptake, apparent diffusion coefficient and post 177Lu-octreotate SPECT/CT dosimetry are reliable predictors ...
Detailed Description
This is a feasibility study evaluating the use of 177Lutetium-octreotate in the treatment of advanced refractory Neuroendocrine Tumors. Objectives of the study: 1. Primary (on a lesion basis): To as...
Eligibility Criteria
Inclusion
- Patient-based:
- Age above or equal to 18 years.
- Histology-proven advanced GEP-NETs.
- Disease progression defined as follows (at least one of the following):
- \- Radiological disease progression (according to RECIST 1.1) on an MRI or CT over the last 12 months Or
- \- Disease progression on a somatostatin receptor-imaging, PET/CT or SPECT/CT over the last 12 months \[apparition of new lesion(s) or increase in the transaxial plane diameter of more than 30% on the same imaging modality\] Or
- \- Both of the following criteria (a+b):
- clinical progression:
- sustained (for more than 2 weeks) increase of NET-specific hormonal hypersecretion related symptom frequency by 50% or,
- sustained (for more than 2 weeks) increase of severity by 1 grade (according to NCI-CTCAE version 4.03).
- biochemical progression: by increase of NET-specific tumor markers (plasma Chromogranin A, plasma NSE, urine 5-HIAA or other) in two successive measurements.
- Disease refractory to SSA's and/or standard systemic therapy available in Belgium at the time of inclusion criteria.
- Long-acting SSAs should be discontinued at least 4 weeks before study treatment start date and, if needed, switched to short-acting analogues which should be stopped 48h before the treatment date.
- Adequate renal function with GFR ≥ 50 mL/min/1.73m2 (evaluated by 51Cr-EDTA test).
- Adequate bone marrow function with hemoglobin ≥ 9 g/dL; neutrophil ≥ 1.5·103/μL; platelet count ≥ 100·103/μL.
- Adequate liver function with total bilirubin ≤ 2 x ULN and transaminases ≤ 5 x ULN, serum albumin \> 3 g/dL with normal prothrombin time (\> 70%).
- ECOG Performance Status ≤ 1.
- Women of childbearing potential and men with partners of childbearing potential must agree to use a highly-effective form of contraception for the duration of study participation and up to six months after the end of the treatment. A pregnancy test (serum) must be performed within 4 weeks prior to inclusion for every female patient of childbearing potential and it must be negative.
- Patient's written informed consent obtained prior to any study procedure.
- All necessary baseline procedures should be performed within 4 weeks prior to first 177Lu-octreotate injection (D0).
- Lesion-based:
- The patient must have at least one target lesion fulfilling all of the below criteria:
- On the 68Ga-octreotate PET/CT: tumor uptake higher than the physiological liver uptake (grade III or IV of the Rotterdam visual score) in a lesion with longest transaxial plane diameter ≥20mm (measured on the CT, part of the PET/CT);
- At least one of these lesions morphologically measurable according to RECIST 1.1 and progressive on the MRI (or CT if MRI is not applicable);
- Target lesion should not have been previously irradiated.
Exclusion
- Resectable tumor with curative intent.
- Any major surgery within the last 6 weeks prior to inclusion in the study
- Radiotherapy, chemotherapy, embolization, mammalian target of rapamycin (mTOR)-inhibitors, receptor tyrosine-kinase inhibitors, interferon, or other investigational therapy within the last 12 weeks prior to inclusion in the study.
- Diffuse bone marrow infiltration on the baseline 68Ga-octreotate PET/CT confirmed by MRI.
- Prior external beam radiotherapy on kidneys or on more than 25% of bone marrow.
- Patients with known uncontrolled brain metastases.
- Patients with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the investigator's opinion, may interfere with completion of the study.
- Pregnant or lactating patients.
- Women of childbearing potential and men with partners of child-bearing potential refusing an adequate contraception.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 19 2022
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT01842165
Start Date
May 1 2013
End Date
September 19 2022
Last Update
November 10 2022
Active Locations (1)
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1
Jules Bordet Institute
Brussels, Belgium, B-1000