TheranosticTrials.org

Clinical Trial · NCT01842165

177Lutetium-octreotate Treatment Prediction Using Multimodality Imaging in Refractory NETs

Overview

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 for lesion-by-lesion treatment outcome.

Sponsor

Jules Bordet Institute

Phase

Phase 3

Contacts

Alain Hendlisz, MD (PRINCIPAL_INVESTIGATOR)

Ioannis Karfis, MD (STUDY_CHAIR)

Patrick Flamen, M.D., Ph.D. (STUDY_CHAIR)

Amélie Deleporte, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT01842165

Drug / Compound

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

DOTATATE

Isotope(s):
Target(s):
  • SSTR2
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • 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);
  • Disease refractory to SSA's and/or standard systemic therapy available in Belgium at the time of inclusion criteria.
  • The patient must have at least one target lesion fulfilling all of the below criteria:
  • biochemical progression: by increase of NET-specific tumor markers (plasma Chromogranin A, plasma NSE, urine 5-HIAA or other) in two successive measurements.
  • 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.
  • 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):
  • 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);
  • Patient-based:
  • Histology-proven advanced GEP-NETs.
  • sustained (for more than 2 weeks) increase of NET-specific hormonal hypersecretion related symptom frequency by 50% or,
  • Target lesion should not have been previously irradiated.

Exclusion

  • 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.
  • Resectable tumor with curative intent.
  • Prior external beam radiotherapy on kidneys or on more than 25% of bone marrow.
  • Women of childbearing potential and men with partners of child-bearing potential refusing an adequate contraception.
  • Patients with known uncontrolled brain metastases.
  • 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.
  • Any major surgery within the last 6 weeks prior to inclusion in the study