NCT01783002

Brief Summary

The overall sensitivity and specificity of 11C-MET PET/CT is superior to 18F-FDG PET/CT and conventional SPECT-CT for the detection of abnormal parathyroid glands.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started May 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 4, 2013

Completed
1.2 years until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

September 18, 2015

Status Verified

September 1, 2015

Enrollment Period

3.8 years

First QC Date

January 4, 2013

Last Update Submit

September 16, 2015

Conditions

Primary Hyperparathyroidism

Outcome Measures

Primary Outcomes (2)

  • To compare the sensitivity of 11C-MET PET/CT, SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism

    Sensitivity is the percentage of patients that were correctly identified to have an abnormal parathyroid gland by the imaging studies.

    Patient will undergo the scans at baseline

  • To compare the specificity of11C-MET PET/CT, SPECT-CT and 18F-FDG PET/CT in the detection of pathologic parathyroid glands in patients with primary hyperparathyroidism

    Specificity is defined as the percentage of patients that were correctly rejected for having an abnormal parathyroid gland by the imaging studies.

    Patient will undergo the scans at baseline

Secondary Outcomes (1)

  • To evaluate the safety profile of 11C-MET PET/CT.

    Up to 2 weeks

Study Arms (1)

Primary hyperparathyroidism

EXPERIMENTAL

Subjects with biochemical evidence, including elevated serum calcium and PTH levels, of primary hyperparathyroidism. All patients will undergo 11C-methionine PET/CT, SPECT-CT and 18F-FDG PET/CT scanning.

Radiation: 11C-Methionine PET/CT scanningRadiation: 18F-FDG PET/CT scanningRadiation: SPECT-CT scanning

Interventions

11C-Methionine PET/CT scanningRADIATION

PET with the radiopharmaceutical carbon-11 methionine (11C-MET) has been considered to improve diagnosis due to a superior spatial resolution and higher specificity compared to other radiotracers such as 18F-FDG. For the 11C-MET PET/CT, the patient will receive an intravenous bolus injection of 11C-MET as manufactured at the BCCA production facility at a dose of 6 (0.16 mCi) MBq per kilogram but not to exceed 555 MBq (15 mCi).

Also known as: 11C-MET
Primary hyperparathyroidism
18F-FDG PET/CT scanningRADIATION

For PET/CT scans, the patient will first receive an intravenous bolus injection of 18F-FDG as manufactured at the BCCA production facility in a dose determined by body weight but not to exceed 521 MBq (14.1 mCi). Our standard adult prescription (70kg adult) for 18F-FDG is 296 MBq (8.0 mCi). The target dose for body scans is increased by 59.2 MBq (1.6 mCi) for every 20 kg increase in body weight to a maximum target dose of 474 MBq (12.8 mCi).

Primary hyperparathyroidism
SPECT-CT scanningRADIATION

For the SPECT-CT scan, each injection of intravenous 99mTc-MIBI is dosed at a maximum of 20 mCi (740MBq), as per usual standard of care. The energy window of each scan is at 140 keV, consistent with the standard of SPEC-CT imaging techniques.

Primary hyperparathyroidism

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \> age 18;
  • Able to provide written informed consent;
  • Subjects with biochemical evidence, including elevated serum calcium and PTH levels, of primary hyperparathyroidism.

You may not qualify if:

  • Subjects with previous successful parathyroidectomy and parathyroid tissue reimplantation;
  • Pregnancy;
  • Subjects who are unable to tolerate the physical/logistical requirements of completing two PET/CT scans, including lying still for a prolonged period of time and receiving two intravenous injections.
  • Subjects who exceed the safe weight limit of the PET/CT bed (204.5 kg) or who cannot fit through the PET/CT machine (diameter 70cm).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

RECRUITING

MeSH Terms

Conditions

Hyperparathyroidism, Primary

Interventions

carbon-11 methionine

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Study Officials

  • Donald W Anderson, MD, FRCSC

    University of British Columbia; Vancouver General Hospital

    PRINCIPAL INVESTIGATOR

  • Don Wilson, MD, FRCPC

    British Columbia Cancer Agency

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hayley Corbett

CONTACT

604-877-6000hayley.corbett@bccancer.bc.ca

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2013

First Posted

February 4, 2013

Study Start

May 1, 2014

Primary Completion

March 1, 2018

Study Completion

July 1, 2018

Last Updated

September 18, 2015

Record last verified: 2015-09

Locations

CA(1)