Medullary Thyroid CarcinomaPEPATI-MN-2024NCT06852144
PET-TC in Thyroid Evaluation
An observational study of Medullary Thyroid Carcinoma and Hyperparathyroidism, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The thyroid gland may have a diffuse or focal uptake of numerous PET/CT radiopharmaceuticals and this may be correlated with underlying benign and malignant thyroid/parathyroid pathologies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medullary Thyroid Carcinoma, Hyperparathyroidism, Parathyroid Carcinoma
- What is being tested?
- clinical practice drug treatment
- How many people
- 418 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2024to 30 Apr 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: Patients belonging to the U.O. of Nuclear Medicine IRCCS - University Hospital of Bologna - Polyclinic S. Orsola, who have performed or are to perform PET/CT for thyroid/parathyroid disease or other clinical indication with incidental detection of thyroid/parathyroid disease or patients undergoing PET/CT with known thyroid/parathyroid disease (for example, patients with thyroid nodules already subjected to needle aspiration) as part of the normal care path for a period of 5 years and 6 months.
Who may be able to join
- For the retrospective part:
- Patients aged >18 years,
- Findings of hypercaptant of thyroid/parathyroid relevance to PET/CT or known thyroid or parathyroid pathology and subsequent execution of PET/CT according to normal clinical practice,
- Patients with cytological examination derived from needle aspiration performed no more than 12 months time apart from PET/CT.
- Obtaining informed consent
- For the prospective part:
Show all 10Show fewer
- Patients aged >18 years,
- Finding hypercaptant findings of thyroid/parathyroid relevance to PET/CT or known thyroid or parathyroid pathology and subsequent execution of PET/CT according to normal clinical practice.
- Patients scheduled for agesult to be no more than 12 months.
- Obtaining informed consent
Who cannot join
- Nothing
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
Nuclear medicine, IRCCS, Azienda Ospedalierio-Universitaria di Bologna
Bologna, Bo, 38050
About this study
Official title: Ruolo Della PET/TC Nella Valutazione di Patologia Tiroidea in un Centro di Medicina Nucleare ad Alto Volume Diagnostico
The thyroid gland may have a diffuse or focal uptake of numerous PET/CT radiopharmaceuticals and this may be correlated with underlying benign and malignant thyroid/parathyroid pathologies.
It is not clear at present if the uptake of the radiopharmaceutical alone is associated with a potential malignancy of the disease.
The aim of the study is to collect evidence and consolidate the diagnostic power of PET/CT, to identify any predictive parameters that can determine whether PET positivity/negativity can in the future avoid unnecessary tests such as needle aspiration.
Read the detailed description
The primary objective of the study is to measure the diagnostic performance of PET/CT (with tracers used in our Center for Nuclear Medicine by normal clinical practice), in the identification of malignancy of thyroid or parathyroid findings, compared to cytological/histological examination in patients with known thyroid and/or parathyroid disease or in patients with incidental findings. The secondary objective is to find functional parameters and predictive imaging of malignancy/benign and risk class of the lesion.
- Being tested
- clinical practice drug treatment
- Keywords
- PET/TC, 18F/FDG, hyperparathyroidism
- Medical subject headings
- Carcinoma, Medullary, Hyperparathyroidism, Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical practice drug treatmentOther
Observational, prospective and retrospective study, transversal, non-profit, monocentric. All data of patients affected/ afferents to theU.O. of Nuclear Medicine of the IRCCS AOU of Bologna will be collected submitted/ who will undergo a PET/ CT investigation for thyroid pathology or other indication with incidental feedback of thyroid uptake and patients who have They undergo PET/CT with known thyroid disease. Of these patients will be collected the personal data, clinical news, data related to PET/ CT (dedicated software e.g. MIM), biochemical/ laboratory and anatomopathological (for operated patients), any other imaging investigations already performed and to be performed later by normal clinical practice. The medical nuclear images will be evaluated by at least two nuclear medical experts, with qualitative, semi-quantitative and radiometric parameters as far as possible. Patients will be treated according to normal clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| pepati group | Patients belonging to the U.O. of Nuclear Medicine IRCCS - University Hospital of Bologna - Polyclinic S. Orsola, who have performed or are to perform PET/CT for thyroid/parathyroid disease or other clinical indication with incidental detection of thyroid/parathyroid disease or patients undergoing PET/CT with known thyroid/parathyroid disease (for example, patients with thyroid nodules already subjected to needle aspiration) as part of the normal care path for a period of 5 years and 6 months. Receives: Other: clinical practice drug treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic performance
Sensitivity, specificity, AUC, detection rate, accuracy, positive and negative predictive value compared to the reference standard.
Measured: 5 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start14 Oct 2024
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Medullary Thyroid 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 418 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06852144
- Sponsor's protocol ID
- PEPATI-MN-2024
- Other IDs
- 322/2024/Oss/AOUBo
- Acronym
- PEPATI-MN-2024
- Status last verified
- Dec 2024
- First submitted
- 11 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cocchiara G, Fazzotta S, Palumbo VD, Damiano G, Cajozzo M, Maione C, Buscemi S, Spinelli G, Ficarella S, Maffongelli A, Caternicchia F, Ignazio Lo Monte A, Buscemi G. The medical and surgical treatment in secondary and tertiary hyperparathyroidism. Review. Clin Ter. 2017 Mar-Apr;168(2):e158-e167. doi: 10.7417/CT.2017.1999.
PubMed 28383630Bertagna F, Albano D, Giovanella L, Giubbini R, Treglia G. F18-choline/C11-choline PET/CT thyroid incidentalomas. Endocrine. 2019 May;64(2):203-208. doi: 10.1007/s12020-019-01841-z. Epub 2019 Jan 12.
PubMed 30637562Marcus C, Whitworth PW, Surasi DS, Pai SI, Subramaniam RM. PET/CT in the management of thyroid cancers. AJR Am J Roentgenol. 2014 Jun;202(6):1316-29. doi: 10.2214/AJR.13.11673.
PubMed 24848831
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ruolo Della PET/TC Nella Valutazione di Patologia Tiroidea in un Centro di Medicina Nucleare ad Alto Volume Diagnostico
- ClinicalTrials.gov ID
- NCT06852144
- Acronym / sponsor ID
- PEPATI-MN-2024 / PEPATI-MN-2024
- Keywords
- PET/TC, 18F/FDG, hyperparathyroidism
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 418 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 28 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.
The thyroid gland may have a diffuse or focal uptake of numerous PET/CT radiopharmaceuticals and this may be correlated with underlying benign and malignant thyroid/parathyroid pathologies.
It is not clear at present if the uptake of the radiopharmaceutical alone is associated with a potential malignancy of the disease.
The aim of the study is to collect evidence and consolidate the diagnostic power of PET/CT, to identify any predictive parameters that can determine whether PET positivity/negativity can in the future avoid unnecessary tests such as needle aspiration.
Detailed description
The primary objective of the study is to measure the diagnostic performance of PET/CT (with tracers used in our Center for Nuclear Medicine by normal clinical practice), in the identification of malignancy of thyroid or parathyroid findings, compared to cytological/histological examination in patients with known thyroid and/or parathyroid disease or in patients with incidental findings. The secondary objective is to find functional parameters and predictive imaging of malignancy/benign and risk class of the lesion.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pepati group | – | Other: clinical practice drug treatmentPatients belonging to the U.O. of Nuclear Medicine IRCCS - University Hospital of Bologna - Polyclinic S. Orsola, who have performed or are to perform PET/CT for thyroid/parathyroid disease or other clinical indication with incidental detection of thyroid/parathyroid disease or patients undergoing PET/CT with known thyroid/parathyroid disease (for example, patients with thyroid nodules already subjected to needle aspiration) as part of the normal care path for a period of 5 years and 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients belonging to the U.O. of Nuclear Medicine IRCCS - University Hospital of Bologna - Polyclinic S. Orsola, who have performed or are to perform PET/CT for thyroid/parathyroid disease or other clinical indication with incidental detection of thyroid/parathyroid disease or patients undergoing PET/CT with known thyroid/parathyroid disease (for example, patients with thyroid nodules already subjected to needle aspiration) as part of the normal care path for a period of 5 years and 6 months.
Key inclusion criteria (10 listed)
- Patients aged >18 years,
- Findings of hypercaptant of thyroid/parathyroid relevance to PET/CT or known thyroid or parathyroid pathology and subsequent execution of PET/CT according to normal clinical practice,
- Patients with cytological examination derived from needle aspiration performed no more than 12 months time apart from PET/CT.
- Obtaining informed consent
- Patients aged >18 years,
Key exclusion criteria (1 listed)
- Nothing
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 |
|---|---|---|
| clinical practice drug treatmentObservational, prospective and retrospective study, transversal, non-profit, monocentric. All data of patients affected/ afferents to theU.O. of Nuclear Medicine of the IRCCS AOU of Bologna will be collected submitted/ who will undergo a PET/ CT investigation for thyroid pathology or other indication with incidental feedback of thyroid uptake and patients who have They undergo PET/CT with known thyroid disease. Of these patients will be collected the personal data, clinical news, data related to PET/ CT (dedicated software e.g. MIM), biochemical/ laboratory and anatomopathological (for operated patients), any other imaging investigations already performed and to be performed later by normal clinical practice. The medical nuclear images will be evaluated by at least two nuclear medical experts, with qualitative, semi-quantitative and radiometric parameters as far as possible. Patients will be treated according to normal clinical practice. | Other | pepati group |
Primary outcome
diagnostic performance
Time frame: 5 years and 6 months
Sensitivity, specificity, AUC, detection rate, accuracy, positive and negative predictive value compared to the reference standard.
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 28 Feb 2025.
- Background: PubMed 28383630Cocchiara G, Fazzotta S, Palumbo VD, Damiano G, Cajozzo M, Maione C, Buscemi S, Spinelli G, Ficarella S, Maffongelli A, Caternicchia F, Ignazio Lo Monte A, Buscemi G. The medical and surgical treatment in secondary and tertiary hyperparathyroidism. Review. Clin Ter. 2017 Mar-Apr;168(2):e158-e167. doi: 10.7417/CT.2017.1999.
- Results publication: PubMed 30637562Bertagna F, Albano D, Giovanella L, Giubbini R, Treglia G. F18-choline/C11-choline PET/CT thyroid incidentalomas. Endocrine. 2019 May;64(2):203-208. doi: 10.1007/s12020-019-01841-z. Epub 2019 Jan 12.
- Results publication: PubMed 24848831Marcus C, Whitworth PW, Surasi DS, Pai SI, Subramaniam RM. PET/CT in the management of thyroid cancers. AJR Am J Roentgenol. 2014 Jun;202(6):1316-29. doi: 10.2214/AJR.13.11673.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Medullary Thyroid Carcinoma and Hyperparathyroidism, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna 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 10 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: enrolling by invitation, as of the sponsor's last update on 28 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 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic performance (time frame: 5 years and 6 months). 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 NCT06852144, which also lists 3 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 28 Feb 2025.