Breast CarcinomaNCT06835426
High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins
A study testing Single intravenous injection of the radiotracer and Imaging resected specimen using the high-resolution PET-CT specimen imager in people with Breast Carcinoma and Prostate Cancer Surgery, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
Trial summary
These are patients in whom a benign or malignant tumor was recorded requiring surgery. During that surgery, the surgeon will cut away the tumor as part of the treatment of the disease. In this process, it is important that the tumor is removed correctly and completely. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Carcinoma, Prostate Cancer Surgery, Thyroid Cancer
- What is being tested?
- Single intravenous injection of the radiotracer and Imaging resected specimen using the high-resolution PET-CT specimen imager
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBelgium
- Study dates
- 6 Aug 2023to 30 Jun 2027
- Phase
- Interventional
- 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
- Inclusion Criteria:
- able to understand treatment protocol and informed consent form
- estimated by the investigator to be compliant for study participation
- Fulfilling all group-specific inclusion criteria:
- confirmed breast cancer with an indication to undergo breast conserving surgery
- confirmed prostate cancer with an indication to undergo resective surgeryprostatectomy;
- confirmed thyroid lesion with an indication to undergo resective surgery;
- confirmed parathyroid adenoma with an indication to undergo resective surgery;
- suspected basal cell carcinoma, squamous cell carcinoma or melanoma with an indication to undergo resective surgery;
- suspected lesion in genitourinary sites (including bladder cancer, renal pelvis and ureter carcinoma, adrenal cortical carcinoma and renal cell carcinoma) with an indication to undergo resective surgery;
- suspected lesion in the head \& neck region with an indication to undergo resective surgery;
- confirmed primary or secondary hepatobiliary cancer with an indication to undergo resective surgery;
- patients undergoing biopsy after metabolic active lesions were detected on a PET scan.
- suspected neuro-endocrine malignancies with an indication to undergo resective surgery.
- suspected brain tumor with an indication to undergo resective surgery.
- Suspected malignant and benign gastrointestinal lesions with an indication to undergo resective surgery.
- suspected malignant thoracovascular lesions with an indication to undergo resective surgery
- Exclusion Criteria:
- general or local contra-indications for resective surgery;
- in case of FDG-based PET tracers: a blood glucose level over 200 mg/dL on the day of surgery;
- pregnancy or lactation;
- participation in other clinical studies with a radiation exposure of more than 1 mSv in the past year.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
AZ Maria Middelares
Ghent, Oost Vlaanderen, 9000
Steffi Ryckaert, Clinical Research Centre Manag, +32 9 246 18 51, steffi.ryckaert@mijnziekenhuis.be
Ine Dauwe, Clinical Research Centre, 003292461852, klinische.studies@mijnziekenhuis.be
About this study
Official title: High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins: an Exploratory Pilot Study
These are patients in whom a benign or malignant tumor was recorded requiring surgery. During that surgery, the surgeon will cut away the tumor as part of the treatment of the disease. In this process, it is important that the tumor is removed correctly and completely. To verify that the correct tissue was completely removed, the tissue is examined microscopically. However, a microscopic analysis takes a relatively long time and the result is not known until a few days after the surgery is completed. If that microscopic analysis should eventually reveal that the tumor was not completely removed, additional treatment is usually necessary. An assessment of the excised tissue during surgery would allow additional tissue to be excised in the same operation if necessary. Thus, in this way, additional treatments can also be avoided. This could lead to shorter treatment time and less emotional strain for the patient, as well as lower costs. To date, however, there are no effective techniques to do this.
PositronEmissionTomography (PET) imaging can be used to image the tumor that needs to be excised. To do this, a tracer must be administered through the blood before the operation. This tracer is a slightly radioactive substance that can be detected by the PET camera even at low concentrations. This technique is already routinely used in the hospital to detect cancer or inflammatory tissue in the body. During this study, however, it's not the intention to look at the tumor while it is still in the patient's body, but rather after it has been cut out of the patient's body by the surgeon. To do this, the piece of tissue cut away will be scanned using a specially designed PET-CT scanner.
The overall goal of this study is to gain additional knowledge. More specifically, the investigators wish to determine which medical conditions may benefit from high-resolution PET-CT specimen imaging.
Read the detailed description
The rationale of this pilot study is to obtain scientific knowledge on the clinical usefulness of perioperative high-resolution PET-CT specimen imaging in different clinical indications and to document the radiation safety of perioperative high-resolution PET-CT specimen imaging.
The study will investigate the clinical value of perioperative high-resolution PET-CT specimen imaging in breast, prostate, thyroid, head \& neck, skin, and primary and secondary hepatobiliary cancer, parathyroid adenoma, brain cancer, suspected malignant and benign gastrointestinal lesions, neuro-endocrine malignancies, genitourinary malignancies (including bladder cancer, renal pelvis and ureter carcinoma, adrenal cortical carcinoma and renal cell carcinoma), thoracovascular malignancies and in patients undergoing biopsy after metabolic active lesions were detected.
The secondary objectives of the study are:
- to correlate the margin status based on high-resolution PET-CT specimen images with the margin status based on microscopic histopathological analysis;
- to compare the visualization of the target lesion between perioperative high-resolution PET-CT specimen imaging and pre-operative standard-of-care imaging (e.g. whole-body PET-CT imaging, MRI imaging etc);
- Conditions
- Breast Carcinoma, Prostate Cancer Surgery, Thyroid Cancer, Parathyroid Adenomas, Skin Cancer, Genitourinary Cancer
- Being tested
- Single intravenous injection of the radiotracer, Imaging resected specimen using the high-resolution PET-CT specimen imager
- Keywords
- resective surgery, perioperative high-resolution PET-CT specimen imaging, breast cancer, Prostate cancer, thyroid cancer, parathyroid cancer, head and neck cancer, neuro-endocrine malignancies, genitourinary malignacies, thoracovascular malignancies
- Medical subject headings
- Breast Neoplasms, Thyroid Neoplasms, Parathyroid Neoplasms, Skin Neoplasms, Urogenital Neoplasms, Head and Neck Neoplasms, Brain Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single intravenous injection of the radiotracerOther
- only in case of 18F-FDG as PET-tracer: blood glucose level is measured;
- single intravenous injection of the radiotracer between 30 minutes and 5 hours (ideally between 60 and 90 minutes) before the specimen is imaged. The type and dose of radiotracer depends on the patient group:
- breast cancer group: 0.8 MBq/kg of 18F-FDG
- prostate cancer group: 1 MBq/kg 18F-PSMA
- thyroid cancer group: 1 MBq/kg of 18F-FDG
- parathyroid adenoma group: 1 MBq/kg of 18F-Choline
- head \& neck cancer group: 1 MBq/kg of 18F-FDG
- skin cancer group: 4 MBq/kg of 18F-FDG
- primary and secondary hepatobiliary tumors group: 1 MBq/kg of 18F-FDG
- genitourinary malignancies group: 1 MBq/kg of 18F-FDG
- metabolic active lesions undergoing biopsy: 1 MBq/kg of 18F-FDG
- Neuro-endocrine malignancies group: 1 MBq/kg of 18F-FDG
- Brain tumor group: 1 MBq/kg of 18F-FDG, 18F-Choline or 18F
- Gastrointestinal group: 1 MBq/kg of 18F-FDG
- Thoracovascular group: 1MBq/kg of 18F-FDG
Imaging resected specimen using the high-resolution PET-CT specimen imagerDiagnostic test
- the resected specimen is imaged in the operation theatre using the high-resolution PET-CT specimen imager (XEOS Aura; XEOS Medical, Ghent, Belgium); in principle no treatment decisions will be taken based on the images acquired by the specimen imager; however a decision to extend the resection can be taken at the discretion of the surgeon if there is clinical suspicion of a positive resection margin;
- additional resected tissue (e.g. lymph nodes, cavity shaves etc) could also be imaged by the high-resolution PET-CT specimen imager; no treatment decisions will be taken based on the images acquired by the specimen imager;
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | This is a single-arm interventional pilot study. Patients eligable for this study who signed the Informed consent will be included and will follow the interventions as described. Receives: Other: Single intravenous injection of the radiotracer; Diagnostic Test: Imaging resected specimen using the high-resolution PET-CT specimen imager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of margin status
to correlate the margin status based on high-resolution PET-CT specimen images with the margin status based on microscopic histopathological analysis
Measured: Up to 2 weeks after surgery (histopathology results)
Secondary outcomes (1)
Comparison of the visualization of the target lesion
post-hoc comparison of the visualization of the target lesion between perioperative high-resolution PET-CT specimen imaging and pre-operative standard-of-care imaging (if recent pre-operative scan available). This will include lesion dimensions (e.g. delineation based on percentage of SUVmax) but also tumor to background ratio variability;
Measured: From pre-operative imaging until imaging during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start6 Aug 2023
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- 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
- Model description
- The rationale of this pilot study is to obtain scientific knowledge on the clinical usefulness of perioperative high-resolution PET-CT specimen imaging in different clinical indications and to document the radiation safety of perioperative high-resolution PET-CT specimen imaging.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Algemeen Ziekenhuis Maria Middelares
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tessa Van Oostveldt, Algemeen Ziekenhuis Maria Middelares
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06835426
- Sponsor's protocol ID
- MMS.2022.048
- Other IDs
- B0172022000009
- Status last verified
- Feb 2025
- First submitted
- 13 Dec 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-resolution PET-CT Specimen Imaging for the Perioperative Visualization of Resection Margins: an Exploratory Pilot Study
- ClinicalTrials.gov ID
- NCT06835426
- Acronym / sponsor ID
- MMS.2022.048
- Conditions
- Breast Carcinoma, Prostate Cancer Surgery, Thyroid Cancer, Parathyroid Adenomas, Skin Cancer, Genitourinary Cancer
- Keywords
- resective surgery, perioperative high-resolution PET-CT specimen imaging, breast cancer, Prostate cancer, thyroid cancer, parathyroid cancer, head and neck cancer, neuro-endocrine malignancies
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Algemeen Ziekenhuis Maria MiddelaresUniversity, hospital or other
- Study start
- 6 Aug 2023 (actual)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 19 Feb 2025 (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.
These are patients in whom a benign or malignant tumor was recorded requiring surgery. During that surgery, the surgeon will cut away the tumor as part of the treatment of the disease. In this process, it is important that the tumor is removed correctly and completely. To verify that the correct tissue was completely removed, the tissue is examined microscopically. However, a microscopic analysis takes a relatively long time and the result is not known until a few days after the surgery is completed. If that microscopic analysis should eventually reveal that the tumor was not completely removed, additional treatment is usually necessary. An assessment of the excised tissue during surgery would allow additional tissue to be excised in the same operation if necessary. Thus, in this way, additional treatments can also be avoided. This could lead to shorter treatment time and less emotional strain for the patient, as well as lower costs. To date, however, there are no effective techniques to do this.
PositronEmissionTomography (PET) imaging can be used to image the tumor that needs to be excised. To do this, a tracer must be administered through the blood before the operation. This tracer is a slightly radioactive substance that can be detected by the PET camera even at low concentrations. This technique is already routinely used in the hospital to detect cancer or inflammatory tissue in the body. During this study, however, it's not the intention to look at the tumor while it is still in the patient's body, but rather after it has been cut out of the patient's body by the surgeon. To do this, the piece of tissue cut away will be scanned using a specially designed PET-CT scanner.
The overall goal of this study is to gain additional knowledge. More specifically, the investigators wish to determine which medical conditions may benefit from high-resolution PET-CT specimen imaging.
Detailed description
The rationale of this pilot study is to obtain scientific knowledge on the clinical usefulness of perioperative high-resolution PET-CT specimen imaging in different clinical indications and to document the radiation safety of perioperative high-resolution PET-CT specimen imaging.
The study will investigate the clinical value of perioperative high-resolution PET-CT specimen imaging in breast, prostate, thyroid, head \& neck, skin, and primary and secondary hepatobiliary cancer, parathyroid adenoma, brain cancer, suspected malignant and benign gastrointestinal lesions, neuro-endocrine malignancies, genitourinary malignancies (including bladder cancer, renal pelvis and ureter carcinoma, adrenal cortical carcinoma and renal cell carcinoma), thoracovascular malignancies and in patients undergoing biopsy after metabolic active lesions were detected.
The secondary objectives of the study are:
- to correlate the margin status based on high-resolution PET-CT specimen images with the margin status based on microscopic histopathological analysis;
- to compare the visualization of the target lesion between perioperative high-resolution PET-CT specimen imaging and pre-operative standard-of-care imaging (e.g. whole-body PET-CT imaging, MRI imaging etc);
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The rationale of this pilot study is to obtain scientific knowledge on the clinical usefulness of perioperative high-resolution PET-CT specimen imaging in different clinical indications and to document the radiation safety of perioperative high-resolution PET-CT specimen imaging.
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Other: Single intravenous injection of the radiotracer, Diagnostic Test: Imaging resected specimen using the high-resolution PET-CT specimen imagerThis is a single-arm interventional pilot study. Patients eligable for this study who signed the Informed consent will be included and will follow the interventions as described. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Single intravenous injection of the radiotracer* only in case of 18F-FDG as PET-tracer: blood glucose level is measured; * single intravenous injection of the radiotracer between 30 minutes and 5 hours (ideally between 60 and 90 minutes) before the specimen is imaged. The type and dose of radiotracer depends on the patient group: * breast cancer group: 0.8 MBq/kg of 18F-FDG * prostate cancer group: 1 MBq/kg 18F-PSMA * thyroid cancer group: 1 MBq/kg of 18F-FDG * parathyroid adenoma group: 1 MBq/kg of 18F-Choline * head \& neck cancer group: 1 MBq/kg of 18F-FDG * skin cancer group: 4 MBq/kg of 18F-FDG * primary and secondary hepatobiliary tumors group: 1 MBq/kg of 18F-FDG * genitourinary malignancies group: 1 MBq/kg of 18F-FDG * metabolic active lesions undergoing biopsy: 1 MBq/kg of 18F-FDG * Neuro-endocrine malignancies group: 1 MBq/kg of 18F-FDG * Brain tumor group: 1 MBq/kg of 18F-FDG, 18F-Choline or 18F * Gastrointestinal group: 1 MBq/kg of 18F-FDG * Thoracovascular group: 1MBq/kg of 18F-FDG | Other | Single arm |
| Imaging resected specimen using the high-resolution PET-CT specimen imager* the resected specimen is imaged in the operation theatre using the high-resolution PET-CT specimen imager (XEOS Aura; XEOS Medical, Ghent, Belgium); in principle no treatment decisions will be taken based on the images acquired by the specimen imager; however a decision to extend the resection can be taken at the discretion of the surgeon if there is clinical suspicion of a positive resection margin; * additional resected tissue (e.g. lymph nodes, cavity shaves etc) could also be imaged by the high-resolution PET-CT specimen imager; no treatment decisions will be taken based on the images acquired by the specimen imager; | Diagnostic test | Single arm |
Primary outcome
Correlation of margin status
Time frame: Up to 2 weeks after surgery (histopathology results)
to correlate the margin status based on high-resolution PET-CT specimen images with the margin status based on microscopic histopathological analysis
1 secondary outcome
Comparison of the visualization of the target lesion
Time frame: From pre-operative imaging until imaging during surgery
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 19 Feb 2025.
- Individual participant dataSharing planned: Undecided
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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?
A study testing Single intravenous injection of the radiotracer and Imaging resected specimen using the high-resolution PET-CT specimen imager in people with Breast Carcinoma and Prostate Cancer Surgery, run by Algemeen Ziekenhuis Maria Middelares at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 19 Feb 2025. 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 Belgium. 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 Tessa Van Oostveldt (+3292468000, klinische.studies@mijnziekenhuis.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of margin status (time frame: Up to 2 weeks after surgery (histopathology results)). 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 19 Feb 2025.