Gastroenteropancreatic Neuroendocrine TumorNCT06155318
68Ga-DOTATOC PET for the Evaluation of Gastroenteropancreatic Neuroendocrine Tumours
An observational study of Gastroenteropancreatic Neuroendocrine Tumor, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) are a heterogeneous group of neoplasms that arise from the endocrine cells of the gastroenteropancreatic tract. The diagnostic work-up of these tumours include Computed Tomography (CT), Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroenteropancreatic Neuroendocrine Tumor
- What is being tested?
- 68Ga-DOTATOC PET as a part of their clinical diagnostic work-up will be included
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteItaly
- Study dates
- 5 Sep 2019to 5 May 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Main selection criteria: patients with GEP-NET referred for 68Ga-DOTATOC PET.
Who may be able to join
- Patients with either histological diagnosis of GEP-NET at radiologic imaging and referred to 68Ga-DOTATOC PET;
- Age > 18 years old;
- Willing to provide a signed informed consent.
Who cannot join
- Controindications to MR study (i.e. Pacemaker);
- Age< 18 years old.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) are a heterogeneous group of neoplasms that arise from the endocrine cells of the gastroenteropancreatic tract.
The diagnostic work-up of these tumours include Computed Tomography (CT), Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI).
Read more
The majority of these tumours express somatostatin receptors on their surface. For this reason, in addition to traditional imaging exams, diagnostic work-up of GEP-NETs should include a Positron Emission Tomography/CT with 68Ga labeled somatostatin analogues targeting somatostatin receptors with high sensitivity and specificity. 68Ga-DOTATOC PET/CT scan is a corner stone to assess GEP- NET patients at different stage of disease and it is the standard functional imaging modality to study well-differentiated Pan-NETs, as reported in the being also included in the guidelines of the European Association of Nuclear Medicine (EANM). Moreover, quantitative parameters extracted from 68Ga- DOTA-peptides PET imaging have demonstrated their prognostic utility as markers for progression-free survival and disease specific mortality in patients affected by NET.
Additionally, 18F-FDG PET can be used for evaluating the possible presence ofa high-grade component within the tumour itself. The accurate morphofunctional characterization is of utmost importance in the field of GEP-NET.
the advent of new hybrid scanners, namely PET/MRI, opens the way to an innovative diagnostic work- up that can be applied to GEP-NETs. In fact, MRI plays a role as morphological imaging modalities for a better characterization of soft-tissue and liver parenchyma compared to CT; moreover, the low radiation exposure related to MRI, makes this imaging modality more suitable for patients requiring several imaging during follow-up.
Patients requiring 68Ga-DOTA peptides (68Ga-DOTATOC) PET scan and eventually MRI scan, can be studied in a single session examination, by using 68Ga-DOTATOC PET/MRI.
Considering the rarity of GEP_NETs, it is quite difficult to collect a sufficient number of patients in order to investigate the accuracy, predictive and prognostic value of the currently available imaging technique in this scenario. Based on these considerations, the possibility to analyze PET images deriving from both PET/CT and PET/MRI scans of patients affected by GEP-NET is of fundamental relevance in order to provide answers to the currently unmet clinical needs.
- Being tested
- 68Ga-DOTATOC PET as a part of their clinical diagnostic work-up will be included
- Medical subject headings
- Gastro-enteropancreatic neuroendocrine tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-DOTATOC PET as a part of their clinical diagnostic work-up will be includedDiagnostic test
Patients meeting the inclusion criteria will undergo 68Ga-DOTATOC PET(PET/MRI or PET/CT) as part of their routine work-up, according to the referral clinicians' indication.PET/MRI will be performed on a 3.0T time of flight PET/MRI. Simultaneous PET/MRI will start approximately 60 minutes after the injection of 68Ga-DOTATOC.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
68GaDOTATOC PET in the identification of the site/s of disease in patients affected by neuroendocrine tumours, both in the staging and restaging phases.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start5 Sep 2019
- Primary completion5 May 2029 (estimated)
- Study completion5 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroenteropancreatic Neuroendocrine TumorStudies 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
- Prospective
- Enrolment
- 300 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
- NCT06155318
- Sponsor's protocol ID
- PET-NET Prospective
- Status last verified
- Dec 2023
- First submitted
- 24 Nov 2023
- Last updated
- 20 Dec 2023
- 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 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga-DOTATOC PET for the Evaluation of Gastroenteropancreatic Neuroendocrine Tumours
- ClinicalTrials.gov ID
- NCT06155318
- Acronym / sponsor ID
- PET-NET Prospective
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 5 May 2029 (estimated)
- Study completion
- 5 May 2029 (estimated)
- First posted
- 4 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.
Gastroenteropancreatic neuroendocrine tumours (GEP-NETs) are a heterogeneous group of neoplasms that arise from the endocrine cells of the gastroenteropancreatic tract.
The diagnostic work-up of these tumours include Computed Tomography (CT), Endoscopic Ultrasound (EUS), Magnetic Resonance Imaging (MRI).
The majority of these tumours express somatostatin receptors on their surface. For this reason, in addition to traditional imaging exams, diagnostic work-up of GEP-NETs should include a Positron Emission Tomography/CT with 68Ga labeled somatostatin analogues targeting somatostatin receptors with high sensitivity and specificity. 68Ga-DOTATOC PET/CT scan is a corner stone to assess GEP- NET patients at different stage of disease and it is the standard functional imaging modality to study well-differentiated Pan-NETs, as reported in the being also included in the guidelines of the European Association of Nuclear Medicine (EANM). Moreover, quantitative parameters extracted from 68Ga- DOTA-peptides PET imaging have demonstrated their prognostic utility as markers for progression-free survival and disease specific mortality in patients affected by NET.
Additionally, 18F-FDG PET can be used for evaluating the possible presence ofa high-grade component within the tumour itself. The accurate morphofunctional characterization is of utmost importance in the field of GEP-NET.
the advent of new hybrid scanners, namely PET/MRI, opens the way to an innovative diagnostic work- up that can be applied to GEP-NETs. In fact, MRI plays a role as morphological imaging modalities for a better characterization of soft-tissue and liver parenchyma compared to CT; moreover, the low radiation exposure related to MRI, makes this imaging modality more suitable for patients requiring several imaging during follow-up.
Patients requiring 68Ga-DOTA peptides (68Ga-DOTATOC) PET scan and eventually MRI scan, can be studied in a single session examination, by using 68Ga-DOTATOC PET/MRI.
Considering the rarity of GEP_NETs, it is quite difficult to collect a sufficient number of patients in order to investigate the accuracy, predictive and prognostic value of the currently available imaging technique in this scenario. Based on these considerations, the possibility to analyze PET images deriving from both PET/CT and PET/MRI scans of patients affected by GEP-NET is of fundamental relevance in order to provide answers to the currently unmet clinical needs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Main selection criteria: patients with GEP-NET referred for 68Ga-DOTATOC PET.
Key inclusion criteria (3 listed)
- Patients with either histological diagnosis of GEP-NET at radiologic imaging and referred to 68Ga-DOTATOC PET;
- Age > 18 years old;
- Willing to provide a signed informed consent.
Key exclusion criteria (2 listed)
- Controindications to MR study (i.e. Pacemaker);
- Age< 18 years old.
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 |
|---|---|---|
| 68Ga-DOTATOC PET as a part of their clinical diagnostic work-up will be includedPatients meeting the inclusion criteria will undergo 68Ga-DOTATOC PET(PET/MRI or PET/CT) as part of their routine work-up, according to the referral clinicians' indication.PET/MRI will be performed on a 3.0T time of flight PET/MRI. Simultaneous PET/MRI will start approximately 60 minutes after the injection of 68Ga-DOTATOC. | Diagnostic test | – |
Primary outcome
Diagnostic Accuracy
Time frame: 10 years
68GaDOTATOC PET in the identification of the site/s of disease in patients affected by neuroendocrine tumours, both in the staging and restaging phases.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- 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.
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 Gastroenteropancreatic Neuroendocrine Tumor, 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 3 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: looking for participants now, as of the sponsor's last update on 20 Dec 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Diagnostic Accuracy (time frame: 10 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 20 Dec 2023.