Parathyroid AdenomaPhase 2/318FCHNCT05891769
99mTc Sestamibi SPECT/CT vs 18F Fluorocholine PET/CT
A Phase 2/3 study testing 18Fluorocholine in people with Parathyroid Adenoma, run by Andrei Iagaru at 1 site in United States.
Trial summary
This study proposes the use of a well-established PET isotope, Fluorine-18 (18F), bound to Choline, for a prospective single-center, single-arm study for participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parathyroid Adenoma
- What is being tested?
- 18Fluorocholine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2023to 1 Jul 2028
- Phase
- Phase 2/3
- 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
Who may be able to join
- Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)
- Negative or equivocal 99mTc Sestamibi SPECT/CT
- Able to provide written consent
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN
- Karnofsky performance status of >50 (or ECOG/WHO equivalent)
- Women must not be pregnant per the Department of Radiology Policy on Imaging in Potentially Pregnant and Pregnant Women.
Who cannot join
- Less than 18 years old at the time of radiotracer administration
- Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x ULN
- QTcF >470 msec on electrocardiogram (ECG) or congenital long QT syndrome
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Stanford Hospital and Clinics
Stanford, California, 94305
Meredith Durbahn, mdurbahn@stanford.edu
Andrei Iagaru, MD
About this study
Official title: Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT
This study proposes the use of a well-established PET isotope, Fluorine-18 (18F), bound to Choline, for a prospective single-center, single-arm study for participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT
- Conditions
- Parathyroid Adenoma
- Being tested
- 18Fluorocholine
- Medical subject headings
- Parathyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18FluorocholineDrug
18F Fluorocholine 5 mCi ± 20% administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| 18FCH PET/CT | Experimental | Participant receive 18F Fluorocholine injection and approximately 45-60 minutes later receive a low dose CT scan from skull base to mid thighs, followed by a static PET emission scan over the same area. Receives: Drug: 18Fluorocholine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of lesions detected by PET/CT for detecting parathyroid adenomas.
Inclusion criteria suggest recruiting patients with negative or equivocal SPECT/CT, so based on this there will be 0 lesions on SPECT/CT. The goal is to compare/count the number of lesions from PET/CT, if any present versus no lesions with SPECT/CT
Measured: up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start27 Sep 2023
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Parathyroid AdenomaStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-center, single-arm study enrolling 100 adult participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andrei Iagaru
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrei Iagaru, Stanford University
- Investigators
- Andrei Iagaru, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891769
- Sponsor's protocol ID
- 68169
- Acronym
- 18FCH
- Status last verified
- Jun 2026
- First submitted
- 26 May 2023
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ciappuccini R, Morera J, Pascal P, Rame JP, Heutte N, Aide N, Babin E, Reznik Y, Bardet S. Dual-phase 99mTc sestamibi scintigraphy with neck and thorax SPECT/CT in primary hyperparathyroidism: a single-institution experience. Clin Nucl Med. 2012 Mar;37(3):223-8. doi: 10.1097/RLU.0b013e31823362e5.
PubMed 22310246Kluijfhout WP, Pasternak JD, Gosnell JE, Shen WT, Duh QY, Vriens MR, de Keizer B, Hope TA, Glastonbury CM, Pampaloni MH, Suh I. 18F Fluorocholine PET/MR Imaging in Patients with Primary Hyperparathyroidism and Inconclusive Conventional Imaging: A Prospective Pilot Study. Radiology. 2017 Aug;284(2):460-467. doi: 10.1148/radiol.2016160768. Epub 2017 Jan 25.
PubMed 28121522Hope TA, Graves CE, Calais J, Ehman EC, Johnson GB, Thompson D, Aslam M, Duh QY, Gosnell JE, Shen WT, Roman SA, Sosa JA, Kluijfhout WP, Seib CD, Villaneuva-Meyer JE, Pampaloni MH, Suh I. Accuracy of 18F-Fluorocholine PET for the Detection of Parathyroid Adenomas: Prospective Single-Center Study. J Nucl Med. 2021 Nov;62(11):1511-1516. doi: 10.2967/jnumed.120.256735. Epub 2021 Mar 5.
PubMed 33674400Graves CE, Hope TA, Kim J, Pampaloni MH, Kluijfhout W, Seib CD, Gosnell JE, Shen WT, Roman SA, Sosa JA, Duh QY, Suh I. Superior sensitivity of 18F-fluorocholine: PET localization in primary hyperparathyroidism. Surgery. 2022 Jan;171(1):47-54. doi: 10.1016/j.surg.2021.05.056. Epub 2021 Jul 21.
PubMed 34301418DeGrado TR, Reiman RE, Price DT, Wang S, Coleman RE. Pharmacokinetics and radiation dosimetry of 18F-fluorocholine. J Nucl Med. 2002 Jan;43(1):92-6.
PubMed 11801711
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Suspected Parathyroid Adenoma and Negative or Equivocal 99mTc Sestamibi SPECT/CT Using 18F Fluorocholine PET/CT
- ClinicalTrials.gov ID
- NCT05891769
- Acronym / sponsor ID
- 18FCH / 68169
- Conditions
- Parathyroid Adenoma
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Andrei IagaruUniversity, hospital or other
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 7 Jun 2023 (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.
This study proposes the use of a well-established PET isotope, Fluorine-18 (18F), bound to Choline, for a prospective single-center, single-arm study for participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-center, single-arm study enrolling 100 adult participants with suspected parathyroid adenoma and negative or equivocal standard of care 99mTc Sestamibi SPECT/CT.
| Arm | Type | Receives |
|---|---|---|
| 18FCH PET/CT | Experimental | Drug: 18FluorocholineParticipant receive 18F Fluorocholine injection and approximately 45-60 minutes later receive a low dose CT scan from skull base to mid thighs, followed by a static PET emission scan over the same area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Suspected parathyroid adenoma (elevated serum calcium and inappropriately normal or high levels of parathyroid hormone)
- Negative or equivocal 99mTc Sestamibi SPECT/CT
- Able to provide written consent
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 5 xULN
Key exclusion criteria (3 listed)
- Less than 18 years old at the time of radiotracer administration
- Creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 60 mL/min or serum creatinine >1.5 x ULN
- QTcF >470 msec on electrocardiogram (ECG) or congenital long QT syndrome
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 |
|---|---|---|
| 18Fluorocholine18F Fluorocholine 5 mCi ± 20% administered intravenously. | Drug | 18FCH PET/CT |
Primary outcome
Number of lesions detected by PET/CT for detecting parathyroid adenomas.
Time frame: up to 1 hour
Inclusion criteria suggest recruiting patients with negative or equivocal SPECT/CT, so based on this there will be 0 lesions on SPECT/CT. The goal is to compare/count the number of lesions from PET/CT, if any present versus no lesions with SPECT/CT
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 24 Jun 2026.
- Background: PubMed 22310246Ciappuccini R, Morera J, Pascal P, Rame JP, Heutte N, Aide N, Babin E, Reznik Y, Bardet S. Dual-phase 99mTc sestamibi scintigraphy with neck and thorax SPECT/CT in primary hyperparathyroidism: a single-institution experience. Clin Nucl Med. 2012 Mar;37(3):223-8. doi: 10.1097/RLU.0b013e31823362e5.
- Background: PubMed 28121522Kluijfhout WP, Pasternak JD, Gosnell JE, Shen WT, Duh QY, Vriens MR, de Keizer B, Hope TA, Glastonbury CM, Pampaloni MH, Suh I. 18F Fluorocholine PET/MR Imaging in Patients with Primary Hyperparathyroidism and Inconclusive Conventional Imaging: A Prospective Pilot Study. Radiology. 2017 Aug;284(2):460-467. doi: 10.1148/radiol.2016160768. Epub 2017 Jan 25.
- Background: PubMed 33674400Hope TA, Graves CE, Calais J, Ehman EC, Johnson GB, Thompson D, Aslam M, Duh QY, Gosnell JE, Shen WT, Roman SA, Sosa JA, Kluijfhout WP, Seib CD, Villaneuva-Meyer JE, Pampaloni MH, Suh I. Accuracy of 18F-Fluorocholine PET for the Detection of Parathyroid Adenomas: Prospective Single-Center Study. J Nucl Med. 2021 Nov;62(11):1511-1516. doi: 10.2967/jnumed.120.256735. Epub 2021 Mar 5.
- Background: PubMed 34301418Graves CE, Hope TA, Kim J, Pampaloni MH, Kluijfhout W, Seib CD, Gosnell JE, Shen WT, Roman SA, Sosa JA, Duh QY, Suh I. Superior sensitivity of 18F-fluorocholine: PET localization in primary hyperparathyroidism. Surgery. 2022 Jan;171(1):47-54. doi: 10.1016/j.surg.2021.05.056. Epub 2021 Jul 21.
- Background: PubMed 11801711DeGrado TR, Reiman RE, Price DT, Wang S, Coleman RE. Pharmacokinetics and radiation dosimetry of 18F-fluorocholine. J Nucl Med. 2002 Jan;43(1):92-6.
- 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.
Andrei Iagaru, MD study director
Stanford University
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 18Fluorocholine in people with Parathyroid Adenoma, run by Andrei Iagaru 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 7 inclusion and 3 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 24 Jun 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 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?
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 Andrea Otte, DPT (650-736-4183, anotte@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lesions detected by PET/CT for detecting parathyroid adenomas. (time frame: up to 1 hour). 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 NCT05891769, which also lists 5 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 24 Jun 2026.