Hyperparathyroidism, PrimaryPhase 2/3NCT03764007
18F-Fluorocholine for the Detection of Parathyroid Adenomas
A Phase 2/3 study testing 18F-Fluorocholine and Positron Emission Tomography (PET) in people with Hyperparathyroidism, Primary, run by Thomas Hope at 1 site in United States.
Trial summary
The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Hyperparathyroidism, Primary
- What is being tested?
- 18F-Fluorocholine and Positron Emission Tomography (PET)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2016to 31 May 2021
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Biochemically proven hyperparathyroidism and an indication for surgery
- Age >= 13 years old
- Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
- Ability to understand a written informed consent document, and the willingness to sign it.
Who cannot join
- Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
- Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.
- Conditions
- Hyperparathyroidism, Primary
- Being tested
- 18F-Fluorocholine, Positron Emission Tomography (PET)
- Keywords
- Positron emission tomography
- Medical subject headings
- Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FluorocholineDrug
Also called Fluorocholine
Given intravenously
Positron Emission Tomography (PET)Procedure or surgery
Also called PET
Imaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
| Study group | Role | What they receive |
|---|---|---|
| 18F-Fluorocholine PET | Experimental | Patients will undergo a single fluorocholine PET imaging study prior to surgery. Receives: Drug: 18F-Fluorocholine; Procedure: Positron Emission Tomography (PET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma
The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.
Measured: Up to 1 year
Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging
The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. In patients who had a sestamibi study performed prior to the fluorocholine imaging study, the original dictated report from the sestamibi will be used for comparison. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.
Measured: Up to 1 year
Secondary outcomes (1)
Detection Rate in Patients Who Have Not Undergone Surgical Resection
The detection rate is defined as the proportion of participants with a 18F-fluorocholine PET positive read who do not subsequently undergo parathyroidectomy, using the dictated reports to determine the detection sensitivity for parathyroid adenomas. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2018
- Study start21 Sep 2016
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hyperparathyroidism, PrimaryStudies 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 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Hope
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Thomas Hope, University of California, San Francisco
- Investigators
- Thomas Hope, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764007
- Sponsor's protocol ID
- 16-19297
- Status last verified
- Aug 2021
- First submitted
- 30 Nov 2018
- Last updated
- 19 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-Fluorocholine for the Detection of Parathyroid Adenomas
- ClinicalTrials.gov ID
- NCT03764007
- Acronym / sponsor ID
- 16-19297
- Conditions
- Hyperparathyroidism, Primary
- Keywords
- Positron emission tomography
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Thomas HopeUniversity, hospital or other
- Study start
- 21 Sep 2016 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 4 Dec 2018 (actual)
- Results
- Posted 19 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are studying the ability of F18 labeled fluorocholine PET to localize parathyroid adenomas in patients with hyperparathyroidism prior to surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-Fluorocholine PET | Experimental | Drug: 18F-Fluorocholine, Procedure: Positron Emission Tomography (PET)Patients will undergo a single fluorocholine PET imaging study prior to surgery. |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Biochemically proven hyperparathyroidism and an indication for surgery
- Age >= 13 years old
- Karnofsky performance status of > 50 (or Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) equivalent).
- Ability to understand a written informed consent document, and the willingness to sign it.
Key exclusion criteria (4 listed)
- Patients exceeding the weight limitations of the scanner or are not able to enter the bore of the PET scanner due to BMI.
- Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.).
- Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.).
- Pregnancy.
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 |
|---|---|---|
| 18F-FluorocholineAlso: FluorocholineGiven intravenously | Drug | 18F-Fluorocholine PET |
| Positron Emission Tomography (PET)Also: PETImaging technique that uses radioactive agents known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities | Procedure or surgery | 18F-Fluorocholine PET |
Primary outcome
Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma
Time frame: Up to 1 year
The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.
Proportion of True Positives for the Detection of the Abnormal Parathyroid Adenoma Using Sestamibi Imaging
Time frame: Up to 1 year
The true positive (sensitivity) rate is defined as the proportion of participants with location of the suspected adenoma on 18F-Fluorocholine PET correlating with location of an abnormal parathyroid at time of participant surgery. For a patient with multiple hyperplastic glands, only one gland needs to correlate for the patient to count as a true positive. In patients who had a sestamibi study performed prior to the fluorocholine imaging study, the original dictated report from the sestamibi will be used for comparison. For analysis, adenomas described as arising in the mid thyroid bed will considered correct if located in either the inferior or superior bed. Patients will be followed-up to determine if they undergo a parathyroidectomy for up to 1 year.
1 secondary outcome
Detection Rate in Patients Who Have Not Undergone Surgical Resection
Time frame: Up to 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Thomas Hope, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 18F-Fluorocholine and Positron Emission Tomography (PET) in people with Hyperparathyroidism, Primary, run by Thomas Hope at 1 site in United States.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 19 Oct 2021. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of True Positives for the Overall Detection of the Abnormal Parathyroid Adenoma (time frame: Up to 1 year). The study lists 2 primary outcomes in all. 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 Oct 2021.