Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas

• Sponsor: David M. Schuster, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01574287
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Arm: 1
• Duration (Months): 81.4
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Hyperparathyroidism (excessive production of parathyroid hormone (PTH) usually caused by a small growth called an adenoma in the parathyroid glands) is an increasingly significant medical and public health condition.

Surgery is the only effective management for primary hyperparathyroidism. However; it is sometimes difficult to pinpoint the adenoma, in part because current methods of imaging often fail to identify the parathyroid adenoma in as many as 30% of patients. In reoperative parathyroidectomy for persistent or recurrent hyperparathyroidism, localization plays an even greater role. Unfortunately current multiple imaging methods fail to localize 10-15% these of tumors.

SPECT/CT with the radiotracer 99mTc sestamibi has become the standard method for pinpointing the tumor. This, however, is a challenge because the parathyroid glands usually are located close to the thyroid and the radiotracer 99mTc sestamibi concentrates both in thyroid and parathyroid tissue. Hence there is a need for a tracer/imaging tool that concentrates in the parathyroid but not in the thyroid.

A more sensitive and specific radiotracer/tracking agent would markedly improve the investigators ability to identify parathyroid tumors preoperatively, and thus offer more patients a minimally invasive parathyroidectomy.

anti-3-[18F]FACBC is an amino acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell culture experiments, anti-3-[18F]FACBC has shown uptake in parathyroid cells greater than thyroid cells. Therefore, the investigators think that this radiotracer may be able to help us identify parathyroid adenomas better than 99mTc sestamibi.

The primary aim of this study is to determine if anti-3-[18F]FACBC PET-CT demonstrates uptake within parathyroid adenomas. 12 patients with a diagnosis of primary hyperparathyroidism will undergo PET-CT using anti-3-[18F]FACBC in addition to the standard 99mTc sestamibi scanning and other imaging as clinically appropriate such as ultrasound, MRI, and/or contrast enhanced CT scanning. Since all these patients undergo surgery routinely, the investigators will then compare findings at surgery to those of the anti-3-[18F]FACBC PET-CT to determine if this radiotracer is worthy of further study in a more comprehensive experiment.

Condition or Disease	Intervention/Treatment	Phase
Parathyroid Disease	Drug: FACBC	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 4 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Amino Acid Transport Imaging of Parathyroid Adenomas With Anti-3-[18F]FACBC
• Study Start Date: Aug 1, 2012
• Actual Primary Completion Date: May 15, 2019
• Actual Study Completion Date: May 15, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FACBC	Drug: FACBC; Drug is give intravenously over 2 minutes at time of scan

Outcome Measures

Primary Outcome Measures

1. Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality [At approximately 1 month post scan (time of surgery and pathologic analysis)]

   Detection rate of parathyroid adenomas using anti-3-[18F]FACBC modality is assessed by comparing [18F]FACBC and surgical findings.

Secondary Outcome Measures

1. Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool [5-10 min after intravenous bolus injection of [18F]fluciclovine]

   To evaluate uptake mechanisms of anti-3-[18F]FACBC, target-to-background ratio (TBR) of anti-3-[18F]FACBC is assessed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients must be 18 years of age or older.

2. Patients will have biochemical and/or clinical evidence of primary hyperparathyroidism and be a surgical candidate for definitive parathyroid surgery .

3. Ability to lie still for PET scanning

4. Patients must be able to provide written informed consent

Exclusion Criteria:

1. Age less than 18.

2. Inability to lie still for PET scanning.

3. Cannot provide written informed consent.

4. History of secondary hyperparathyroidism.

5. Positive serum or urine pregnancy test within 24 hours of imaging

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30032

Sponsors and Collaborators

• David M. Schuster, MD

Investigators

• Principal Investigator: David M Schuster, MD, Emory University

Study Documents (Full-Text)

• Study Protocol - Nov 22, 2013
• Statistical Analysis Plan - Jun 13, 2019

More Information

Publications

None provided.

• Responsible Party: David M. Schuster, MD, Sponsor-Investigator, Emory University
• ClinicalTrials.gov Identifier: NCT01574287
• Other Study ID Numbers: IRB00051415
• First Posted: Apr 10, 2012
• Last Update Posted: Jul 2, 2019
• Last Verified: Jun 1, 2019

• Additional relevant MeSH terms: Adenoma; Parathyroid Neoplasms; Parathyroid Diseases

Study Results

Participant Flow

Arm/Group Title	FACBC
Arm/Group Description	FACBC: Drug is give intravenously over 2 minutes at time of scan
Period Title: Overall Study
STARTED	4
COMPLETED	4
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	FACBC
Arm/Group Description	FACBC: Drug is give intravenously over 2 minutes at time of scan
Overall Participants	4
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	57 (9)
Sex: Female, Male (Count of Participants)
Female	3 75%
Male	1 25%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	4 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%

Outcome Measures

1. Primary Outcome

Title	Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality
Description	Detection rate of parathyroid adenomas using anti-3-[18F]FACBC modality is assessed by comparing [18F]FACBC and surgical findings.
Time Frame	At approximately 1 month post scan (time of surgery and pathologic analysis)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FACBC
Arm/Group Description	FACBC: Drug is give intravenously over 2 minutes at time of scan
Measure Participants	4
Number [percentage of adenomas detected]	80

2. Secondary Outcome

Title	Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool
Description	To evaluate uptake mechanisms of anti-3-[18F]FACBC, target-to-background ratio (TBR) of anti-3-[18F]FACBC is assessed
Time Frame	5-10 min after intravenous bolus injection of [18F]fluciclovine

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	FACBC
Arm/Group Description	FACBC: Drug is give intravenously over 2 minutes at time of scan
Measure Participants	4
Mean (Standard Deviation) [SUVmax]	1.3 (0.6)

Adverse Events

Time Frame	1 month
Arm/Group Title	FACBC
Arm/Group Description	FACBC: Drug is give intravenously over 2 minutes at time of scan
All Cause Mortality
	FACBC
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Serious Adverse Events
	FACBC
	Affected / at Risk (%)	# Events
Total	0/4 (0%)
Other (Not Including Serious) Adverse Events
	FACBC
	Affected / at Risk (%)	# Events
Total	0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.