Spanish Series of Patients Treated With the Radionuclide Lutetium177 (SEPTRALU)

December 22, 2022 updated by: Sociedad Española de Medicina Nuclear e Imagen Molecular

SEPTRALU, Spanish Series of Patients Treated With the Radionuclide Lutetium177

This study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patient data will be collected from medical records after obtaining consent and retrospectively.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08041
        • Not yet recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
      • Burgos, Spain, 09006
      • Ciudad Real, Spain, 13005
        • Recruiting
        • Hospital General Universitario de Ciudad Real
        • Contact:
      • Madrid, Spain, 28034
        • Not yet recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
      • Madrid, Spain, 28046
      • Madrid, Spain, 28041
        • Not yet recruiting
        • Hospital Universitario 12 de Octubre
        • Contact:
      • Madrid, Spain, 28007
        • Not yet recruiting
        • Hospital General Universitario Gregorio Maranon
        • Contact:
      • Madrid, Spain, 28050
        • Not yet recruiting
        • Hospital Universitario HM Sanchinarro
        • Contact:
      • Pamplona, Spain, 31008
      • Valencia, Spain, 46026
      • Valencia, Spain, 46017
    • A Coruña
      • Santiago De Compostela, A Coruña, Spain, 15706
        • Recruiting
        • Hospital Clínico Universitario de Santiago
        • Contact:
    • Andalucia
      • Granada, Andalucia, Spain, 18014
        • Recruiting
        • Hospital Universitario Virgen de Las Nieves
        • Contact:
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
        • Contact:
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Not yet recruiting
        • Hospital Universitari de Bellvitge
        • Contact:
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Spain, 07120
    • Madrid
      • Getafe, Madrid, Spain, 28905
        • Not yet recruiting
        • Hospital Universitario de Getafe
        • Contact:
      • Majadahonda, Madrid, Spain, 28222
        • Not yet recruiting
        • Hospital Univeritario Puerta de Hierro
        • Contact:
    • Murcia
      • El Palmar, Murcia, Spain, 30120
        • Recruiting
        • Hospital Clinico Universitario Virgen de La Arrixaca
        • Contact:
    • Navarra
      • Pamplona, Navarra, Spain, 31008

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study plans to enroll patients with unresectable or metastatic, progressive, somatostatin receptor positive tumors.

Description

Inclusion Criteria:

  • Written informed consent must be obtained prior to any data collection.
  • Patients must be diagnosed with unresectable or metastatic, progressive, somatostatin receptor positive tumour
  • Aged ≥18 years.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Lutathera
Drug: Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Other Names:
  • Lutathera
Device: Lutetium [177Lu] oxodotreotide/dotatate
Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
Other Names:
  • Lutathera

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Up to 12 months
Defined as the time, in months, from Lutathera® treatment initiation to the date of first objective tumour progression, determined according to Response Evaluation Criteria in Solid Tumours (RECIST) Criteria, Version 1.1, or death due to any cause, whichever comes first.
Up to 12 months
Overall survival (OS)
Time Frame: Up to 12 months
Defined as the time, in months, from Lutathera® treatment initiation to the date of death due to any cause.
Up to 12 months
Overall response rate (ORR)
Time Frame: Up to 12 months
Is determined by imaging technique according to RECIST criteria v1.1 and is defined as the proportion of treated patients who achieve a best overall response of partial response (PR) or complete response (CR) according to RECIST 1.1
Up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Characteristics of the population .
Time Frame: Up to 12 months
Description of the main characteristics of the population studied, treatments received (before and after lutetium) and evolution.
Up to 12 months
Adverse Events (AEs)
Time Frame: Up to 12 months
Toxicity will be collected according to grades (NCT-CTCAE) and consequences.
Up to 12 months
Prognostic factors
Time Frame: Up to 12 months
Correlation of possible prognostic factors with clinical effectiveness outcomes.
Up to 12 months
Areas for improvement care
Time Frame: Up to 12 months
Identification of areas for improvement in the management and selection of patients for treatment with lutathera
Up to 12 months
Health-related Quality of Life (HRQoL)
Time Frame: Up to 12 months
Assess the impact of treatment on health-related Quality of Life (HRQoL) by EORTC QLQ-G.I.NET-21 questionnaire.The minimum value ( 1%) and the maximum value (100%), and higher scores mean a better outcome.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sociedad Española de Medicina Nuclear e Imagen Molecular

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mercedes Dr Mitjavila Casanovas, MD-PhD, Sociedad Española de Medicina Nuclear e Imagen Molecular (SEMNIM)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2034

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SEM-LUT-2020-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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