Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03324893
Other study ID # 16-5153
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 3, 2018
Est. completion date June 23, 2021

Study information

Verified date December 2023
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A prospective trial comparing the accuracy of [F-18]-FCH PET/MRI to US and 99mTc-MIBI SPECT/CT for pre-operative parathyroid localization in patients with primary hyperparathyroidism


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date June 23, 2021
Est. primary completion date June 23, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Biochemically proven primary hyperparathyroidism - Indication for parathyroidectomy as per institutional guidelines Exclusion Criteria: - Contraindication for MRI as per current institutional guidelines. - Contraindication for Gadolinium injection as per current institutional guidelines. - Renal failure - Inability to lie supine for at least 45 minutes. - Any participant who is pregnant or breastfeeding. - Participants receiving erythropoietin (i.e. for hemochromatosis; might lead to false negative results due to stimulation of bone marrow metabolism) - Familial HPT syndromes - Participant currently being treated with any cytotoxic chemotherapy

Study Design


Intervention

Diagnostic Test:
[F-18]-FCH PET/MRI
Subjects will undergo the [F-18]-FCH PET/MRI within three months prior to scheduled parathyroidectomy.

Locations

Country Name City State
Canada UHN Toronto Ont

Sponsors (1)

Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy of [F-18]-FCH PET/MRI in localization of diseased parathyroid gland Value of [F-18]-FCH PET/MRI next to Ultrasound of the Neck and 99mTc-MIBI SPECT/CT in determining which of the four parathyroid glands
Reference standards:
Intra-operative location of the hyper functioning gland by inspection and post-operative pathological confirmation.
Determination of biochemical cure per usual standard of care: intraoperative PTH and calcium and PTH postoperatively.
1 month postoperatively
See also
  Status Clinical Trial Phase
Recruiting NCT04555642 - Early Diagnosis of Therapy-associated Cardiotoxicity Basing on Multi-tracer Multimodality PET/MRI
Recruiting NCT05004961 - The Performance of Multi-tracer Multimodality PET in Lymphoma
Recruiting NCT05188872 - Application of 68Ga-Pentixafor PET/CT in Primary Aldosteronism and Pre-postoperative of SAAE N/A
Recruiting NCT04983095 - Metastasis Directed Stereotactic Body Radiotherapy for Oligo Metastatic Hormone Sensitive Prostate Cancer Phase 3
Recruiting NCT05610098 - Gene Expression Profiles in Spinal Tuberculosis.
Recruiting NCT04416165 - Comparison of FDG and FAPI in Patients With Various Types of Cancer N/A
Recruiting NCT04750772 - Positron Nuclide Labeled DOTA-FAPI PET Study in Colocrectal Cancer N/A
Recruiting NCT04831541 - 68Ga-PSMA-11 PET/CT in Patients With Various Types of Cancer Early Phase 1
Recruiting NCT06017973 - The Role of Imaging in the Diagnosis, Management and Prognosis of Possible Non-convulsive Status Epilepticus N/A
Recruiting NCT06188468 - ImmunoPET Targeting Trophoblast Cell-surface Antigen 2 (Trop-2) in Solid Tumors N/A
Recruiting NCT03830242 - Diagnostic Significance of FDG PET/CT Dynamic Imaging in Detecting Metastatic Lymph Nodes With Papillary Thyroid Cancer. N/A
Recruiting NCT06387381 - 68Ga-PSFA PET Imaging in Patients With PSMA/FAP Positive Disease Early Phase 1
Recruiting NCT05506566 - 68Ga-FAP-CHX PET/CT : Dosimetry and Preliminary Clinical Translational Studies Phase 1/Phase 2
Not yet recruiting NCT04367948 - Positron Nuclide Labeled NOTA-FAPI PET Study in Lymphoma N/A
Recruiting NCT05757804 - Study of 18F-0502B PET Imaging Targeting α-synuclein in the Diagnosis of α-synuclein-related Diseases
Completed NCT05392205 - Comaprison of 68Ga-FAP-2286 and 18F-FDG PET/CT in Patients With Various Types of Cancer N/A
Completed NCT03741231 - 18FDG-PET in Patients With Melanoma or NSCLC Treated With Immunotherapy
Completed NCT01035164 - Evaluation of ZK 6032924 in Probable Alzheimer's Disease Patients Versus Healthy Volunteers and the Radiation Dosimetry of ZK 6032924 in Healthy Volunteers Phase 1
Completed NCT03107663 - ⁸⁹Zr-Df-IAB22M2C PET/CT in Patients With Selected Solid Malignancies or Hodgkin's Lymphoma Phase 1
Recruiting NCT03636607 - Diagnostic Significance of Single Center, Open and Prospective Evaluation of <Sup>18<Sup>F-FDG PET/CT Dynamic Imaging and Genomic Sequencing in Detecting Metastatic Lesions of Primary Hepatocellular Carcinoma N/A