A Retrospective Data Analysis of Therapy With PRRT Combined With Lanreotide Autogel® for Neuroendocrine Tumours

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The objective of the PRELUDE study is to describe the use of lanreotide Autogel® (LAN ATG) combined with Peptide Receptor Radionuclide Therapy (PRRT) in the treatment of progressive neuroendocrine tumours located in the lung or in the digestive system as there is currently limited data on these treatments used together for these types of neuroendocrine tumours.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy and Safety of Lanreotide Autogel/ Depot 120 mg vs. Placebo in Subjects With Lung Neuroendocrine Tumours

NCT02683941

Neuroendocrine Tumors in Lung

TERMINATED PHASE3

Combination of Lanreotide Autogel 120mg and Temozolomide in Progressive GEP-NET

NCT02231762

Gastroenteropancreatic Neuroendocrine Tumors

COMPLETED PHASE2

Personalized PRRT of Neuroendocrine Tumors

NCT02754297

Neuroendocrine Tumors Carcinoid Tumor Carcinoma, Neuroendocrine

ACTIVE_NOT_RECRUITING PHASE2

Study of PRRT in Metastatic, World Health Organization (WHO) Grade 1 or 2, SSTR Positive, GEP-NET Who Are Candidates for Cytoreductive Surgery

NCT04609592

Gastroenteropancreatic Neuroendocrine Tumor

RECRUITING PHASE1

Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors (Phase 2)

NCT04790708

Neuroendocrine Tumors Peptide Receptor Radionuclide Therapy (PRRT)

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Neuroendocrine Tumours

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histopathologically confirmed metastatic well differentiated Neuroendocrine Tumour (NET) (Grade G1 or G2 according to the World Health Organisation 2010 classification): Gastro-entero-pancreatic (GEP) or Bronchopulmonary (BP) primary tumour, or tumour of unknown origin believed to be of GEP origin, if a primary tumour elsewhere was excluded by multiphasic computerised tomography (CT) or magnetic resonance imaging (MRI)
* Disease progression radiologically documented with evaluable imaging (CT or MRI, digital or print-out), performed within 12 months and within 6 months prior to the first PRRT/LAN ATG cycle
* Metastatic- or locally-advanced, hormonal functioning or nonfunctioning GEP-NET or BP-NET;
* Confirmed presence of Somatostatin Receptors (SSTRs) on all target lesions based on positive SSTR scintigraphy (Octreoscan®/99mTC-tektrotyd) or 68Ga SSTR Positron Emission Tomography-Computerised Tomography (PET/CT) imaging, i.e. Grade ≥2 respectively per the Krenning scale or per the modified Krenning scale

Exclusion Criteria

* Absence of information regarding LAN ATG treatment: dose received, start date, frequency of injections
* No CT or MRI within 12 months and within 6 months preceding the baseline, or at the end of the last PRRT/LAN ATG cycle
* Absence of information on cumulative activity of PRRT with 177 Lutetium (177Lu) DOTATOC or 177Lu-DOTATATE received (at least 500 mCi (equivalent to 18.5 GBq), for the entire therapy)
* PRRT prior to the first combination cycle of PRRT/LAN ATG

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No