Breast CancerSURGYPETNCT06474975
Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer
A study testing AURA 10 PET/CT in people with Breast Cancer and Breast-conserving Surgery, run by European Institute of Oncology at 1 site in Italy.
Trial summary
This study is a diagnostic open-label, prospective, single-arm non-inferiority clinical trial. The primary endpoint is the accuracy to detect positive invasive margins in invasive ductal carcinoma (IDC) patients by high-resolution specimen Positron Emission Tomography/Computed Tomography (PET/CT) imaging. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast-conserving Surgery
- What is being tested?
- AURA 10 PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2024to Jul 2026
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- females with an age over 18 years;
- confirmed breast cancer with indication to undergo BCS (stage I-II with tumor ≤2.5 in greatest dimension);
- vacuum-assisted core breast biopsy is allowed for non-invasive tumors only;
- able to understand treatment protocol and informed consent form;
- estimated by the investigator to be compliant for study participation.
Who cannot join
- general or local contra-indication for BCS;
- previous breast surgery;
- inflammatory breast cancer;
- radiotherapy of the ipsilateral breast;
- vacuum-assisted core breast biopsy for all patients with invasive tumors (vacuum-assisted core breast biopsy is allowed for patients with non-invasive tumors as long as the residual tumor size on mammogram is at least 1.0 cm);
- pregnancy or lactation;
- participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year;
- active bacterial, viral or fungal infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SURGYPET: Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer as Compared to Gross Pathology: a Prospective Non-inferiority Analysis
This study is a diagnostic open-label, prospective, single-arm non-inferiority clinical trial.
The primary endpoint is the accuracy to detect positive invasive margins in invasive ductal carcinoma (IDC) patients by high-resolution specimen Positron Emission Tomography/Computed Tomography (PET/CT) imaging.
Read the detailed description
The rationale of this study is to examine the non-inferiority of intraoperative high-resolution specimen PET/CT imaging in early-stage breast cancer for the identification of all positive margins of the invasive component during Breast Cancer Surgery (BCS) as compared to standard-of-care gross pathology evaluation.
The PET/CT specimen imager is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard.
- Conditions
- Breast Cancer, Breast-conserving Surgery
- Being tested
- AURA 10 PET/CT
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AURA 10 PET/CTDevice
Also called PET/CT specimen imager (AURA 10 PET/CT)
The PET/CT specimen imager (AURA 10 PET/CT) is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard
| Study group | Role | What they receive |
|---|---|---|
| Identification of positive margins with PET/CT specimen imager | Experimental | Identification of all positive margins of the invasive component during BCS using PET/CT specimen imager Receives: Device: AURA 10 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the accuracy to detect positive invasive margins in IDC patients
Evaluation of intraoperative high-resolution specimen PET/CT imaging for the identification of all invasive positive margins during primary breast-conserving surgery (BCS) of invasive ductal carcinoma (IDC), as compared to perioperative gross pathology evaluation. Permanent pathology is used as the gold standard for margin assessment.
Measured: 1 month
Secondary outcomes (3)
Evaluation of diagnostic performance of PET/CT in the detection of positive margins respect to gross pathology
determining the diagnostic performance of intraoperative high-resolution specimen PET/CT imaging and gross pathology to detect all positive margin;
Measured: 1 month
Detection of malignant cells in resected lymph nodes and cavity shaves
exploring the ability of intraoperative high-resolution specimen PET/CT imaging to detect the presence of malignant cells in resected lymph nodes and cavity shaves;
Measured: 1 month
Definition of optimal SUVmax cut-off
determining the optimal SUVmax cut-off in intraoperative high-resolution specimen PET/CT imaging for the correct detection of malignant vs. non-malignant tissues, using pathology results as standard-of-reference
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Ceci, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474975
- Sponsor's protocol ID
- L2-092
- Acronym
- SURGYPET
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SURGYPET: Intra-SURGerY High-resolution Specimen PET/CT Imager for Margin Assessment in Early-stage Breast Cancer as Compared to Gross Pathology: a Prospective Non-inferiority Analysis
- ClinicalTrials.gov ID
- NCT06474975
- Acronym / sponsor ID
- SURGYPET / L2-092
- Conditions
- Breast Cancer, Breast-conserving Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 26 Jun 2024 (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.
This study is a diagnostic open-label, prospective, single-arm non-inferiority clinical trial.
The primary endpoint is the accuracy to detect positive invasive margins in invasive ductal carcinoma (IDC) patients by high-resolution specimen Positron Emission Tomography/Computed Tomography (PET/CT) imaging.
Detailed description
The rationale of this study is to examine the non-inferiority of intraoperative high-resolution specimen PET/CT imaging in early-stage breast cancer for the identification of all positive margins of the invasive component during Breast Cancer Surgery (BCS) as compared to standard-of-care gross pathology evaluation.
The PET/CT specimen imager is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Identification of positive margins with PET/CT specimen imager | Experimental | Device: AURA 10 PET/CTIdentification of all positive margins of the invasive component during BCS using PET/CT specimen imager |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- females with an age over 18 years;
- confirmed breast cancer with indication to undergo BCS (stage I-II with tumor ≤2.5 in greatest dimension);
- vacuum-assisted core breast biopsy is allowed for non-invasive tumors only;
- able to understand treatment protocol and informed consent form;
- estimated by the investigator to be compliant for study participation.
Key exclusion criteria (8 listed)
- general or local contra-indication for BCS;
- previous breast surgery;
- inflammatory breast cancer;
- radiotherapy of the ipsilateral breast;
- vacuum-assisted core breast biopsy for all patients with invasive tumors (vacuum-assisted core breast biopsy is allowed for patients with non-invasive tumors as long as the residual tumor size on mammogram is at least 1.0 cm);
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 |
|---|---|---|
| AURA 10 PET/CTAlso: PET/CT specimen imager (AURA 10 PET/CT)The PET/CT specimen imager (AURA 10 PET/CT) is used to intraoperatively assess resection margins and histopathological findings of the breast tumor specimen are applied as the gold standard | Device | Identification of positive margins with PET/CT specimen imager |
Primary outcome
Evaluation of the accuracy to detect positive invasive margins in IDC patients
Time frame: 1 month
Evaluation of intraoperative high-resolution specimen PET/CT imaging for the identification of all invasive positive margins during primary breast-conserving surgery (BCS) of invasive ductal carcinoma (IDC), as compared to perioperative gross pathology evaluation. Permanent pathology is used as the gold standard for margin assessment.
3 secondary outcomes
Evaluation of diagnostic performance of PET/CT in the detection of positive margins respect to gross pathology
Time frame: 1 month
Detection of malignant cells in resected lymph nodes and cavity shaves
Time frame: 1 month
Definition of optimal SUVmax cut-off
Time frame: 1 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
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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.
Francesco Ceci principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AURA 10 PET/CT in people with Breast Cancer and Breast-conserving Surgery, run by European Institute of Oncology 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 5 inclusion and 8 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 26 Jun 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 Francesco Ceci, MD (+390257489315, francesco.ceci@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the accuracy to detect positive invasive margins in IDC patients (time frame: 1 month). 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 26 Jun 2024.