The LuMEn Trial: 177Lu-octreotate Treatment Outcome Prediction Using Multimodality Imaging in Refractory Neuroendocrine Tumours.
18 Years
N/A
Both
Gastroenteropancreatic Neuroendocrine Tumors
Trial Information
The LuMEn Trial: 177Lu-octreotate Treatment Outcome Prediction Using Multimodality Imaging in Refractory Neuroendocrine Tumours.
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 assess the value of the following parameters (obtained
through functional and molecular imaging) for predicting the lesion-by-lesion treatment
outcome: 68Ga-octreotate and 18FDG uptake on PET/CT scans as well as apparent diffusion
coefficient on diffusion-weighted magnetic resonance imaging (absolute values at
baseline and after each cycle and their relative differences) and post 177Lu-octreotate
SPECT/CT dosimetry after each cycle.
2. secondary (on a patient basis): To generate a patient-based response model based on the
aforementioned parameters.
Treatment will consist of 177Lu-octreotate infusions in fixed activities of 7,4 GigaBecqurel
each, given 8-11 weeks apart, injected intravenously with simultaneous infusion of an amino
acid solution. (Before amino acid nephroprotection solution, ondansetron, methylprednisolone
and metoclopramid, are given intravenously in order to prevent nausea or vomiting).
Approximately 30 min after the beginning of the amino acid solution, 177Lu-octreotate is
co-infused over 15-30 minutes. The amino acid infusion is continued at the same rate for 3-5
more hours (total infusion lasts 4-6 hours).
In total, 4 cycles are planned. However, the total number of administered cycles will be
limited by critical organ (kidneys and bone marrow) cumulated absorbed doses.
Treatment efficacy will be assessed:
- on a lesion-basis (change of longest transversal diameter).
- on a patient-basis using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Inclusion Criteria:
1. Patient-based
- Age above 18 years.
- Histology-proven advanced Gastroenteropancreatic-Neuroendocrine tumors.
- Proven disease progression:(2 from the below criteria must be present)
1. clinically: sustained (for more than 2 weeks) increase by 50% of
NET-specific symptoms frequency (diarrhea or flushes), or of severity by 1
grade (according to CTCAE version 4.03),
2. biochemically, by significant increase in tumoral markers (plasma
Chromogranin A,
3. radiologically, according to RECIST 1.1 criteria on a CT or MRI (over 1
year).
- Disease refractory to somatostatine analogues and/or standard systemic therapy
available in Belgium at the time of inclusion criteria.
- Adequate renal function with GFR≥50 mL/min.
- Adequate bone marrow function with Hemoglobin≥9 g/dL; WBC≥2000/μL; platelet
count≥100000/μL.
- Adequate liver function with bilirubin total ≤2 x upper limit of normal (ULN)
and transaminases ≤5 x ULN., serum albumin>3,0gr/dL with normal prothrombin time
(>70%).
- Eastern Cooperative Oncology Group Performance Status ≤1.
- Women of childbearing potential and men 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 serum pregnancy test will also be
performed prior inclusion.
- Patient's written informed consent obtained prior to any study procedure.
2. Lesion-based: The patient must have at least one target lesion fulfilling all of the
below criteria:
- 68Ga-octreotate PET/CT (performed within a period of 3 weeks after signature of
the informed consent form: tumoral uptake higher than the physiological liver
uptake in a lesion with short-axis diameter superior to 15mm (measured on
PET/CT),
- at least one of these lesions morphologically measurable on the MRI with RECIST
1.1 (or CT if MRI is not applicable),
- target lesion should not have been previously irradiated.
Exclusion Criteria:
- Possible surgery with curative intent.
- Surgery, radiotherapy, chemotherapy, within the last 6 weeks.
- Diffuse bone marrow infiltration on 68Ga-octreotate PET/CT confirmed by MRI.
- Patients with known uncontrolled brain metastases.
- Short-acting somatostatin analogues not interrupted for 48 hours before or
long-acting somatostatin not interrupted for at minimum of 4 weeks before therapy.
- Subjects with another significant medical, psychiatric, or surgical condition,
currently uncontrolled by treatment, which, in the investigator's opinion, may
interfere with completion of the study.
- Pregnancy. Women of child-bearing potential refusing an adequate contraception.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
the difference in the diameter for each target lesion after each cycle of the treatment measured on MRI (or on CT scan if MRI is not applicable)
Outcome Time Frame:
3 years [Anticipated]
Safety Issue:
No
Principal Investigator
Patrick Flamen, M.D., Ph.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jules Bordet Institute
Authority:
Belgium: Federal Agency for Medicinal Products and Health Products
Study ID:
IJBMNLUMEN
NCT ID:
NCT01842165
Start Date:
May 2013
Completion Date:
May 2016
Related Keywords:
- Gastroenteropancreatic Neuroendocrine Tumors
- Peptide Receptor Radionuclide Therapy (PRRT)
- Neuroendocrine Tumors
- Neuroendocrine Tumors
- Intestinal Neoplasms
- Pancreatic Neoplasms
- Stomach Neoplasms
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