Neuroendocrine TumorsNCT06159920
Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Neuroendocrin Tumors.
An observational study of Neuroendocrine Tumors, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Neuroendocrine tumors (NETs) constitute approximately 0.5% of malignancies. To date, diagnosis at an increasingly early stage of the disease is possible thanks to recent technological advances in biomedical imaging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors
- What is being tested?
- diagnostic accuracy
- How many people
- 800 participants
- Where
- 1 siteItaly
- Study dates
- 27 Oct 2021to 27 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this study, adult patients suffering from neuroendocrine tumors who have undergone PET examination (PET/CT or PET/MRI) with 18F-FDG or 68Ga-DOTATOC at the U.0 of Nuclear medicine at the RCCS San Raffaele will be considered for clinical reasons both in the staging and restaging phases.
Who may be able to join
- Adult patients affected by neuroendocrine tumors; Patients who have performed at least one PET study with 18F-FDG and/or 68Ga- DOTATOC for the staging or diagnosis of their pathology.
Who cannot join
- Patients < 18 years old;
- Lack of availability of clinical data and PET imaging useful for analyses.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Irccs San Raffaele
Milan, Italia
Alessandra Maielli, 0226432716, maielli.alessandra@hsr.it
About this study
Neuroendocrine tumors (NETs) constitute approximately 0.5% of malignancies. To date, diagnosis at an increasingly early stage of the disease is possible thanks to recent technological advances in biomedical imaging. In particular, the traditional work-up for these pathologies includes endoscopy, magnetic resonance imaging (MRI) and computed tomography (CT). Furthermore, the integrated positron emission tomography methods (PET/CT and PET/MRI) are innovative molecular imaging techniques and represent a continually expanding field of research in the oncology setting. In particular, PET is taking on an increasingly relevant role for the study of neuroendocrine tumors, also thanks to the introduction of increasingly accurate radiopharmaceuticals (targeted towards somatostatin receptors), thus opening the way to new possibilities for the diagnosis andcharacterization of these tumors, is in the staging and restaging phase .
- Conditions
- Neuroendocrine Tumors
- Being tested
- diagnostic accuracy
- Medical subject headings
- Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic accuracyDiagnostic test
The aim of this retrospective study is to evaluate the diagnostic and prognostic value of PET/MRI and PET/CT with the use of different radiopharmaceuticals (68Ga-DOTATOC -edotreotide, and 18F-FDG - fluorodeoxyglucose) for the study of patients suffering from neuroendocrine tumors. To this end, both traditional imaging parameters and the contribution of radiomic features will be investigated. The latter are quantitative features extracted from biomedical images, and are believed to be able to provide information, otherwise impossible to investigate, useful for the characterization of various pathologies.
What is being measured
The primary outcome is the main question the study is designed to answer.
800 patients suffering from neuroendocrine tumors who have undergone PET examination (PET/CT or PET/MRI) with 18F-FDG or 68Ga-DOTATOC.
The integrated positron emission tomography methods (PET/CT and PET/MRI) are innovative molecular imaging techniques, for the diagnosis and characterization of these tumors.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start27 Oct 2021
- Primary completion27 Dec 2024 (estimated)
- Study completion27 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159920
- Sponsor's protocol ID
- PET-NET-Retrospective
- Status last verified
- Mar 2024
- First submitted
- 27 Nov 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diagnostic and Prognostic Role of PET (PET/CT and PET/MRI) in Neuroendocrin Tumors.
- ClinicalTrials.gov ID
- NCT06159920
- Acronym / sponsor ID
- PET-NET-Retrospective
- Conditions
- Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 27 Dec 2024 (estimated)
- Study completion
- 27 Dec 2024 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Neuroendocrine tumors (NETs) constitute approximately 0.5% of malignancies. To date, diagnosis at an increasingly early stage of the disease is possible thanks to recent technological advances in biomedical imaging. In particular, the traditional work-up for these pathologies includes endoscopy, magnetic resonance imaging (MRI) and computed tomography (CT). Furthermore, the integrated positron emission tomography methods (PET/CT and PET/MRI) are innovative molecular imaging techniques and represent a continually expanding field of research in the oncology setting. In particular, PET is taking on an increasingly relevant role for the study of neuroendocrine tumors, also thanks to the introduction of increasingly accurate radiopharmaceuticals (targeted towards somatostatin receptors), thus opening the way to new possibilities for the diagnosis andcharacterization of these tumors, is in the staging and restaging phase .
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, adult patients suffering from neuroendocrine tumors who have undergone PET examination (PET/CT or PET/MRI) with 18F-FDG or 68Ga-DOTATOC at the U.0 of Nuclear medicine at the RCCS San Raffaele will be considered for clinical reasons both in the staging and restaging phases.
Key inclusion criteria (1 listed)
- Adult patients affected by neuroendocrine tumors; Patients who have performed at least one PET study with 18F-FDG and/or 68Ga- DOTATOC for the staging or diagnosis of their pathology.
Key exclusion criteria (2 listed)
- Patients < 18 years old;
- Lack of availability of clinical data and PET imaging useful for analyses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diagnostic accuracyThe aim of this retrospective study is to evaluate the diagnostic and prognostic value of PET/MRI and PET/CT with the use of different radiopharmaceuticals (68Ga-DOTATOC -edotreotide, and 18F-FDG - fluorodeoxyglucose) for the study of patients suffering from neuroendocrine tumors. To this end, both traditional imaging parameters and the contribution of radiomic features will be investigated. The latter are quantitative features extracted from biomedical images, and are believed to be able to provide information, otherwise impossible to investigate, useful for the characterization of various pathologies. | Diagnostic test | – |
Primary outcome
800 patients suffering from neuroendocrine tumors who have undergone PET examination (PET/CT or PET/MRI) with 18F-FDG or 68Ga-DOTATOC.
Time frame: 2 years
The integrated positron emission tomography methods (PET/CT and PET/MRI) are innovative molecular imaging techniques, for the diagnosis and characterization of these tumors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuroendocrine Tumors, run by IRCCS San Raffaele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arturo Chiti (0226432716, chiti.arturo@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
800 patients suffering from neuroendocrine tumors who have undergone PET examination (PET/CT or PET/MRI) with 18F-FDG or 68Ga-DOTATOC. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.