Novel digital multi-modality imaging for the diagnosis of parathyroid adenoma
| ISRCTN | ISRCTN75047591 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75047591 |
- Submission date
- 07/03/2023
- Registration date
- 13/04/2023
- Last edited
- 13/04/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background study and aims
The main function of the parathyroid glands is to regulate the calcium balance in the body, which is important for processes like nerve and muscle function as well as skeletal structure. Normally, you have four glands, usually located next to the thyroid gland, but it also happens that they can be located somewhere else in the neck or the chest. In parathyroid hyperfunction, one or more parathyroid glands produce too much parathyroid hormone (adenoma), which is something that could lead patients to suffer from kidney, musculoskeletal and heart problems, among others. Previous to treatment, which is usually surgery, localization of the adenoma is usually performed using SPECT (single photon emission computed tomography) and/or contrast-enhanced computed tomography (CT), in two different sessions. Multimodality equipment using SPECT and CT in one session could result in advantages for the patient and the healthcare system. This study aims to evaluate the diagnostic performance of the combination of SPECT and contrast-enhanced 3-phase CT (without contrast and with contrast in arterial and venous phases) for the detection and localization of parathyroid adenoma.
Who can participate?
Adult patients with clinical suspicion of parathyroid adenoma
What does the study involve?
We will perform a contrast-enhanced SPECT-CT in a novel CZT camera
What are the possible benefits and risks of participation?
The expected benefit is the detection, location and anatomical characterization of a suspected parathyroid adenoma. Potential risks would be an adverse reaction to intravenous iodinated contrast.
Where is the study run from?
Clinical Physiology Department, Nuclear Medicine Unit, Linköping University Hospital (Sweden)
When is the study starting and how long is it expected to run for?
August 2018 to March 2023
Who is funding the study?
Linköping University Hospital, Clinical Physiology Department and Radiology Department (Sweden)
Who is the main contact?
Miguel Ochoa Figueroa, MD, PhD, miguel.ochoa.figueroa@regionostergotland.se (Sweden)
Contact information
Principal Investigator
Fysiologiska Kliniken
Universitetssjukhuset
Linköping
581 85
Sweden
 ORCID ID |
0000-0001-9444-8225 |
|---|---|
| Phone | +46 101039090 |
| miguel.ochoa.figueroa@regionostergotland.se |
Scientific
Fysiologiska Kliniken
Universitetssjukhuset
Linköping
581 85
Sweden
| Phone | +46 101039090 |
|---|---|
| miguel.ochoa.figueroa@regionostergotland.se |
Public
Fysiologiska Kliniken
Universitetssjukhuset
Linköping
581 85
Sweden
| Phone | +46 101039090 |
|---|---|
| miguel.ochoa.figueroa@regionostergotland.se |
Study information
| Study design | Observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case series |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| Scientific title | Contrast enhanced digital CZT SPECT-CT for the diagnosis of parathyroid adenoma |
| Study objectives | The use of novel CZT SPECT-CT using intravenous contrast increases the detection rates of parathyroid adenomas. |
| Ethics approval(s) | Approved 06/03/2019, the Ethics Review Authority in Sweden (Etikprövningsmyndigheten, Box 2110, Uppsala, 750 02, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: 2019-00501 |
| Health condition(s) or problem(s) studied | Parathyroid adenoma |
| Intervention | This is a study that included patients with suspected parathyroid adenoma who are referred to our Hospital for an imaging study called parathyroid scintigraphy. We will perform the scintigraphy using a new digital cadmium zinc telluride (CZT) camera which has the ability to acquire 3D images and contrast-enhanced CT at the same time. Both studies are routinely performed in our centre and are well-established studies in these patients worldwide. The approach is to do both at the same time, in order to save time and resources, using a one-stop-shop approach. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Scintigraphy using a digital cadmium zinc telluride (CZT) camera |
| Primary outcome measure | Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of the test with and without intravenous contrast measured using a digital CZT (cadmium-zinc-telluride) multimodality equipment SPECT-CT (single-photon emission computed tomography-computed tomography) at one timepoint during diagnosis of suspected parathyroid adenoma |
| Secondary outcome measures | Accuracy, sensitivity, specificity, positive predictive value and negative predictive value of the test of the information provided by a combination of SPECT and CT = contrast-enhanced SPECT-CT, measured using HU (Hounsfield units) of the native, arterial and venous phases in the CT images and the wash-out of the tracer in the SPECT images at one timepoint |
| Overall study start date | 18/08/2018 |
| Completion date | 30/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 45 |
| Key inclusion criteria | Adult patients referred from the endocrinology department with suspicion of parathyroid adenoma |
| Key exclusion criteria | Allergy to iodinated contrast media |
| Date of first enrolment | 09/05/2021 |
| Date of final enrolment | 30/03/2023 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Linköping
581 85
Sweden
Sponsor information
Hospital/treatment centre
C/o: Kjell Jansson. MD, PhD
Chief of the Department of Clinical Physiology
University Hospital
Linköping
58185
Sweden
| Phone | +46 10 105 96 35 |
|---|---|
| Kjell.Jansson@regionostergotland.se | |
| Website | http://www.regionostergotland.se/ |
"ROR" |
https://ror.org/05h1aye87 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- Linköping University, Linköping University, LiU
- Location
- Sweden
Results and Publications
| Intention to publish date | 30/03/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon reasonable request. Miguel Ochoa Figueroa, MD, PhD. miguel.ochoa.figueroa@regionostergotland.se. Consent from participants was required and obtained. The type of data that can be shared will depend on what is permitted by Swedish law. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Statistical Analysis Plan | 08/03/2023 | No | No |
Additional files
Editorial Notes
08/03/2023: Trial's existence confirmed by the Ethics Review Authority (Sweden).
