Patients Undergoing PET/CT Investigation or Nuclear Medicine TherapyAI-basedMedNucNCT07174089
New AI-based Technologies in Nuclear Medicine
An observational study of Patients Undergoing PET/CT Investigation or Nuclear Medicine Therapy, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial summary
The study aims to identify and predict radiopharmaceutical extravasation events using new semi-quantitative parameters and machine learning models. It involves dose rate measurements to develop metrics for real-time monitoring. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Patients Undergoing PET/CT Investigation or Nuclear Medicine Therapy
- What is being tested?
- RadEye SPRD-ER device: spectrometric radiation detector capable of detecting gamma radiation.
- Type of treatment
- Injection or infusion
- How many people
- 1,500 participants
- Where
- 1 siteItaly
- Study dates
- 30 Jul 2021to 31 Dec 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing standard-of-care nuclear medicine procedures (PET/CT or therapeutic α/β radiopharmaceutical administrations).
Who may be able to join
- patients undergoing PET/CT scans or therapeutic treatments with radiopharmaceuticals labelled with alpha or beta emitting nuclides
Who cannot join
- patients whose clinical or psychological conditions do not allow for their involvement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda USL IRCCS di Reggio Emilia
Reggio Emilia
Mauro Iori, MD
About this study
Official title: New AI-based Technologies for Even Safer and More Precise Nuclear Medicine
The study aims to identify and predict radiopharmaceutical extravasation events using new semi-quantitative parameters and machine learning models. It involves dose rate measurements to develop metrics for real-time monitoring. It also investigates the correlation between extravasation and SUV correction in PET/CT diagnostics, providing an estimate of the correction factor necessary for accurate SUV evaluation in case of an extravasation event.
Read the detailed description
This is a descriptive, observational, non-profit study aimed at detecting and predicting extravasation events during the administration of radiopharmaceuticals for diagnostic and therapeutic purposes in nuclear medicine. Extravasation can lead to local tissue damage and compromise the accuracy of semi-quantitative imaging parameters such as the Standardized Uptake Value (SUV), widely used in PET/CT for diagnosis, staging, and therapy response evaluation. Literature reports that extravasation may cause a 21-50% change in SUV, potentially leading to incorrect assessment of tumor response.
The study will use a CE-marked portable spectroscopic personal radiation detector (RadEye SPRD-ER, Thermo Fisher Scientific™), already validated in a previous Ethics Committee-approved study, to record dose-rate (DR) curves during radiopharmaceutical injections. Using these data, new dosimetric metrics will be developed to characterize correct, abnormal, and extravasation events. Machine learning (ML) algorithms will be trained on patient clinical data, injection metrics, and DR curves to classify injection events in real time and to estimate correction factors for SUV quantification. Monte Carlo simulations (MCNP code, anthropomorphic phantoms, and reconstructed patient geometries) will be performed to evaluate absorbed dose distributions in extravascular regions.
The project is structured into three phases:
Phase 1 (Data Acquisition \& Analysis): Real-time monitoring with RadEye SPRD-ER, extraction of quantitative metrics (DRmax, DRmean, Δp, t*, Δt), development of ML classifiers and regression models for SUV correction.
Phase 2 (Monte Carlo Simulations): Activity and dose calibration, dose distribution modeling in extravascular tissues.
Phase 3 (Dissemination): Scientific publications and presentation of results at international conferences.
This study has the potential to improve safety, diagnostic reliability, and accuracy of radiopharmaceutical administrations by introducing predictive monitoring and real-time correction of quantitative imaging parameters.
- Being tested
- RadEye SPRD-ER device: spectrometric radiation detector capable of detecting gamma radiation.
- Keywords
- extravasation, SUV, radioligand therapy, radiopharmaceutical, dosimetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadEye SPRD-ER device: spectrometric radiation detector capable of detecting gamma radiation.Other
Acquisition of data during the infusion of PET radiotracers and the administration of α and β emitting radiopharmaceuticals for therapy.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing radiotherapy | The individuals studied will all be patients administered with radiopharmaceuticals for diagnostic and therapy purposes (aged between 18 and 90). Receives: Other: RadEye SPRD-ER device: spectrometric radiation detector capable of detecting gamma radiation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of new semi-quantitative metrics to detect extravasation events
Identification and validation of quantitative parameters derived from dose-rate (DR) curves capable of reliably distinguishing between normal injection, abnormal venous retention, and extravasation events. Metrics will be applicable to both therapeutic radiopharmaceuticals (α and β emitters) and diagnostic radiotracers (e.g., PET/CT)
Measured: During and immediately after radiopharmaceutical injection
Secondary outcomes (1)
Correlation between extravasation severity and SUV alterations in nuclear medicine diagnostics
Identification and quantification of the relationship between the extent of radiopharmaceutical extravasation and changes in Standardized Uptake Value (SUV) in diagnostic imaging. This analysis will be performed using Monte Carlo simulations and OLINDA software for activity estimation and dosimetric calibration. Patient-specific imaging data (CT, PET) will be used to model extravasation events and evaluate their impact on SUV quantification.
Measured: within 90 minutes after radiopharmaceutical administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2025
- Study start30 Jul 2021
- Primary completion30 Sep 2022
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Patients Undergoing PET/CT Investigation or Nuclear Medicine TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174089
- Sponsor's protocol ID
- 267/2022/SPER/IRCCSRE
- Acronym
- AI-basedMedNuc
- Status last verified
- May 2026
- First submitted
- 4 Sep 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wilson S, Osborne D, Long M, Knowland J, Fisher DR. Practical Tools for Patient-specific Characterization and Dosimetry of Radiopharmaceutical Extravasation. Health Phys. 2022 Nov 1;123(5):343-347. doi: 10.1097/HP.0000000000001600. Epub 2022 Jul 15.
PubMed 35838538Iori M, Grassi E, Piergallini L, Meglioli G, Botti A, Sceni G, Cucurachi N, Verzellesi L, Finocchiaro D, Versari A, Fraboni B, Fioroni F. Safety injections of nuclear medicine radiotracers: towards a new modality for a real-time detection of extravasation events and 18F-FDG SUV data correction. EJNMMI Phys. 2023 May 23;10(1):31. doi: 10.1186/s40658-023-00556-5.
PubMed 37221434Tylski P, Pina-Jomir G, Bournaud-Salinas C, Jalade P. Tissue dose estimation after extravasation of 177Lu-DOTATATE. EJNMMI Phys. 2021 Mar 31;8(1):33. doi: 10.1186/s40658-021-00378-3.
PubMed 33788043Kiser JW, Benefield T, Lattanze RK, Ryan KA, Crowley J. Assessing and Reducing Positron Emission Tomography/Computed Tomography Radiotracer Infiltrations: Lessons in Quality Improvement and Sustainability. JCO Oncol Pract. 2020 Jul;16(7):e636-e640. doi: 10.1200/JOP.19.00302. Epub 2020 Feb 11.
PubMed 32045542Williams JM, Arlinghaus LR, Rani SD, Shone MD, Abramson VG, Pendyala P, Chakravarthy AB, Gorge WJ, Knowland JG, Lattanze RK, Perrin SR, Scarantino CW, Townsend DW, Abramson RG, Yankeelov TE. Towards real-time topical detection and characterization of FDG dose infiltration prior to PET imaging. Eur J Nucl Med Mol Imaging. 2016 Dec;43(13):2374-2380. doi: 10.1007/s00259-016-3477-3. Epub 2016 Aug 25.
PubMed 27557845Osborne D, Lattanze R, Knowland J, Bryant TE, Barvi I, Fu Y, Kiser JW. The Scientific and Clinical Case for Reviewing Diagnostic Radiopharmaceutical Extravasation Long-Standing Assumptions. Front Med (Lausanne). 2021 Jun 28;8:684157. doi: 10.3389/fmed.2021.684157. eCollection 2021.
PubMed 34262915Bilgic S. FDG Extravasation in PET/CT Imaging: A Visual Grading Approach Based on Clinical Observations. J Med Imaging Radiat Oncol. 2025 Sep;69(6):617-625. doi: 10.1111/1754-9485.13876. Epub 2025 Jul 2.
PubMed 40600568van der Pol J, Voo S, Bucerius J, Mottaghy FM. Consequences of radiopharmaceutical extravasation and therapeutic interventions: a systematic review. Eur J Nucl Med Mol Imaging. 2017 Jul;44(7):1234-1243. doi: 10.1007/s00259-017-3675-7. Epub 2017 Mar 16.
PubMed 28303300
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New AI-based Technologies for Even Safer and More Precise Nuclear Medicine
- ClinicalTrials.gov ID
- NCT07174089
- Acronym / sponsor ID
- AI-basedMedNuc / 267/2022/SPER/IRCCSRE
- Keywords
- extravasation, SUV, radioligand therapy, radiopharmaceutical, dosimetry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 15 Sep 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.
The study aims to identify and predict radiopharmaceutical extravasation events using new semi-quantitative parameters and machine learning models. It involves dose rate measurements to develop metrics for real-time monitoring. It also investigates the correlation between extravasation and SUV correction in PET/CT diagnostics, providing an estimate of the correction factor necessary for accurate SUV evaluation in case of an extravasation event.
Detailed description
This is a descriptive, observational, non-profit study aimed at detecting and predicting extravasation events during the administration of radiopharmaceuticals for diagnostic and therapeutic purposes in nuclear medicine. Extravasation can lead to local tissue damage and compromise the accuracy of semi-quantitative imaging parameters such as the Standardized Uptake Value (SUV), widely used in PET/CT for diagnosis, staging, and therapy response evaluation. Literature reports that extravasation may cause a 21-50% change in SUV, potentially leading to incorrect assessment of tumor response.
The study will use a CE-marked portable spectroscopic personal radiation detector (RadEye SPRD-ER, Thermo Fisher Scientific™), already validated in a previous Ethics Committee-approved study, to record dose-rate (DR) curves during radiopharmaceutical injections. Using these data, new dosimetric metrics will be developed to characterize correct, abnormal, and extravasation events. Machine learning (ML) algorithms will be trained on patient clinical data, injection metrics, and DR curves to classify injection events in real time and to estimate correction factors for SUV quantification. Monte Carlo simulations (MCNP code, anthropomorphic phantoms, and reconstructed patient geometries) will be performed to evaluate absorbed dose distributions in extravascular regions.
The project is structured into three phases:
Phase 1 (Data Acquisition \& Analysis): Real-time monitoring with RadEye SPRD-ER, extraction of quantitative metrics (DRmax, DRmean, Δp, t*, Δt), development of ML classifiers and regression models for SUV correction.
Phase 2 (Monte Carlo Simulations): Activity and dose calibration, dose distribution modeling in extravascular tissues.
Phase 3 (Dissemination): Scientific publications and presentation of results at international conferences.
This study has the potential to improve safety, diagnostic reliability, and accuracy of radiopharmaceutical administrations by introducing predictive monitoring and real-time correction of quantitative imaging parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing radiotherapy | – | Other: RadEye SPRD-ER device: spectrometric radiation detector capable of detecting gamma radiation.The individuals studied will all be patients administered with radiopharmaceuticals for diagnostic and therapy purposes (aged between 18 and 90). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing standard-of-care nuclear medicine procedures (PET/CT or therapeutic α/β radiopharmaceutical administrations).
Key inclusion criteria (1 listed)
- patients undergoing PET/CT scans or therapeutic treatments with radiopharmaceuticals labelled with alpha or beta emitting nuclides
Key exclusion criteria (1 listed)
- patients whose clinical or psychological conditions do not allow for their involvement
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 |
|---|---|---|
| RadEye SPRD-ER device: spectrometric radiation detector capable of detecting gamma radiation.Acquisition of data during the infusion of PET radiotracers and the administration of α and β emitting radiopharmaceuticals for therapy. | Other | Patients undergoing radiotherapy |
Primary outcome
Characterization of new semi-quantitative metrics to detect extravasation events
Time frame: During and immediately after radiopharmaceutical injection
Identification and validation of quantitative parameters derived from dose-rate (DR) curves capable of reliably distinguishing between normal injection, abnormal venous retention, and extravasation events. Metrics will be applicable to both therapeutic radiopharmaceuticals (α and β emitters) and diagnostic radiotracers (e.g., PET/CT)
1 secondary outcome
Correlation between extravasation severity and SUV alterations in nuclear medicine diagnostics
Time frame: within 90 minutes after radiopharmaceutical administration
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 29 May 2026.
- Background: PubMed 35838538Wilson S, Osborne D, Long M, Knowland J, Fisher DR. Practical Tools for Patient-specific Characterization and Dosimetry of Radiopharmaceutical Extravasation. Health Phys. 2022 Nov 1;123(5):343-347. doi: 10.1097/HP.0000000000001600. Epub 2022 Jul 15.
- Background: PubMed 37221434Iori M, Grassi E, Piergallini L, Meglioli G, Botti A, Sceni G, Cucurachi N, Verzellesi L, Finocchiaro D, Versari A, Fraboni B, Fioroni F. Safety injections of nuclear medicine radiotracers: towards a new modality for a real-time detection of extravasation events and 18F-FDG SUV data correction. EJNMMI Phys. 2023 May 23;10(1):31. doi: 10.1186/s40658-023-00556-5.
- Background: PubMed 33788043Tylski P, Pina-Jomir G, Bournaud-Salinas C, Jalade P. Tissue dose estimation after extravasation of 177Lu-DOTATATE. EJNMMI Phys. 2021 Mar 31;8(1):33. doi: 10.1186/s40658-021-00378-3.
- Background: PubMed 32045542Kiser JW, Benefield T, Lattanze RK, Ryan KA, Crowley J. Assessing and Reducing Positron Emission Tomography/Computed Tomography Radiotracer Infiltrations: Lessons in Quality Improvement and Sustainability. JCO Oncol Pract. 2020 Jul;16(7):e636-e640. doi: 10.1200/JOP.19.00302. Epub 2020 Feb 11.
- Background: PubMed 27557845Williams JM, Arlinghaus LR, Rani SD, Shone MD, Abramson VG, Pendyala P, Chakravarthy AB, Gorge WJ, Knowland JG, Lattanze RK, Perrin SR, Scarantino CW, Townsend DW, Abramson RG, Yankeelov TE. Towards real-time topical detection and characterization of FDG dose infiltration prior to PET imaging. Eur J Nucl Med Mol Imaging. 2016 Dec;43(13):2374-2380. doi: 10.1007/s00259-016-3477-3. Epub 2016 Aug 25.
- Background: PubMed 34262915Osborne D, Lattanze R, Knowland J, Bryant TE, Barvi I, Fu Y, Kiser JW. The Scientific and Clinical Case for Reviewing Diagnostic Radiopharmaceutical Extravasation Long-Standing Assumptions. Front Med (Lausanne). 2021 Jun 28;8:684157. doi: 10.3389/fmed.2021.684157. eCollection 2021.
- Background: PubMed 40600568Bilgic S. FDG Extravasation in PET/CT Imaging: A Visual Grading Approach Based on Clinical Observations. J Med Imaging Radiat Oncol. 2025 Sep;69(6):617-625. doi: 10.1111/1754-9485.13876. Epub 2025 Jul 2.
- Background: PubMed 28303300van der Pol J, Voo S, Bucerius J, Mottaghy FM. Consequences of radiopharmaceutical extravasation and therapeutic interventions: a systematic review. Eur J Nucl Med Mol Imaging. 2017 Jul;44(7):1234-1243. doi: 10.1007/s00259-017-3675-7. Epub 2017 Mar 16.
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 Patients Undergoing PET/CT Investigation or Nuclear Medicine Therapy, run by Azienda USL Reggio Emilia - IRCCS 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 1 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 29 May 2026. 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 Mauro Iori, MD (0522/296655, mauro.iori@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterization of new semi-quantitative metrics to detect extravasation events (time frame: During and immediately after radiopharmaceutical injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07174089, which also lists 8 linked publications.
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 29 May 2026.