NCT01842165

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 for lesion-by-lesion treatment outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 14, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2022

Completed
Last Updated

November 10, 2022

Status Verified

November 1, 2022

Enrollment Period

8.7 years

First QC Date

April 25, 2013

Last Update Submit

November 7, 2022

Conditions

Gastroenteropancreatic Neuroendocrine Tumors

Keywords

Peptide Receptor Radionuclide Therapy (PRRT)Neuroendocrine Tumors

Outcome Measures

Primary Outcomes (1)

  • The time to progression (TTP) for each target lesion assessed on MRI (or on CT scan if MRI is not possible).

    TTP is defined as the time between treatment initiation and objective tumor progression with censoring of patients who die as a result of any cause.

    4 years [Anticipated]

Secondary Outcomes (3)

  • Best morphological response according to RECIST 1.1

    4 years [Anticipated]

  • Progression Free Survival

    4 years [Anticipated]

  • Biochemical response (evolution of NET-specific tumoral uptake).

    4 years [Anticipated]

Other Outcomes (1)

  • The time to progression (TTP) for each target lesion assessed on MRI (or on CT scan if MRI is not applicable).

    4 years [Anticipated]

Study Arms (1)

177Lu-octreotate therapy

OTHER

Treatment will consist of 177Lu-octreotate injections in fixed activities of 7,4 GBq (200 mCi) (±5%) each, given 12 weeks (±1 week) apart, injected intravenously simultaneously with nephroprotective perfusion of an amino acid solution.

Drug: Intravenous injection of 177Lu-octreotate

Interventions

Intravenous injection of 177Lu-octreotateDRUG

Treatment will consist of 177Lu-octreotate injections in fixed activities of 7,4 GBq (200 mCi) (±5%) each, given 12 weeks (±1 week) apart, injected intravenously simultaneously with nephroprotective perfusion of an amino acid solution.

Also known as: 177Lu-DOTATATE, Lutate
177Lu-octreotate therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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%).
  • +8 more criteria

You may not qualify if:

  • Resectable tumor with curative intent.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jules Bordet Institute

Brussels, B-1000, Belgium

Location

Related Publications (3)

  • Danieli R, Mileva M, Marin G, Kristanto P, Delbart W, Vanderlinden B, Wimana Z, Hendlisz A, Levillain H, Reynaert N, Flamen P, Karfis I. Evolution of dosimetric parameters through PRRT and potential impact on clinical practice: data from the prospective phase II LUMEN study. EJNMMI Res. 2024 Nov 18;14(1):110. doi: 10.1186/s13550-024-01163-w.

    PMID: 39557730DERIVED

  • Mileva M, Van Bogaert C, Marin G, Danieli R, Artigas C, Levillain H, Ameye L, Taraji-Schiltz L, Stathopoulos K, Wimana Z, Hendlisz A, Flamen P, Karfis I. 177 Lu-DOTATATE PRRT Safety and Organ-at-Risk Dosimetry in Patients With Gastroenteropancreatic Neuroendocrine Tumors : Data From the Prospective Phase 2 LUMEN Study. Clin Nucl Med. 2024 Sep 1;49(9):847-853. doi: 10.1097/RLU.0000000000005330. Epub 2024 Jun 19.

    PMID: 38914016DERIVED

  • Mileva M, Marin G, Levillain H, Artigas C, Van Bogaert C, Marin C, Danieli R, Deleporte A, Picchia S, Stathopoulos K, Jungels C, Vanderlinden B, Paesmans M, Ameye L, Critchi G, Taraji-Schiltz L, Velghe C, Wimana Z, Bali M, Hendlisz A, Flamen P, Karfis I. Prediction of 177Lu-DOTATATE PRRT Outcome Using Multimodality Imaging in Patients with Gastroenteropancreatic Neuroendocrine Tumors: Results from a Prospective Phase II LUMEN Study. J Nucl Med. 2024 Feb 1;65(2):236-244. doi: 10.2967/jnumed.123.265987.

    PMID: 38164576DERIVED

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

lutetium Lu 177 dotatate

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Patrick Flamen, M.D., Ph.D.

    Jules Bordet Institute

    STUDY CHAIR

  • Amélie Deleporte, MD

    Jules Bordet Institute

    PRINCIPAL INVESTIGATOR

  • Alain Hendlisz, MD

    Jules Bordet Institute

    PRINCIPAL INVESTIGATOR

  • Ioannis Karfis, MD

    Jules Bordet Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2013

First Posted

April 29, 2013

Study Start

May 1, 2013

Primary Completion

January 14, 2022

Study Completion

September 19, 2022

Last Updated

November 10, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)