Standard PET/CT vs. Digital PET/CT

NCT ID: NCT03081767

Last Updated: 2022-04-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-29

Study Completion Date

2021-04-01

Brief Summary

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The investigators wish to determine if standard and digital PET/CT scanners provide equivalent results for disease detection and diagnosis.

Detailed Description

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There will be a single injection of the PET radiopharmaceutical followed by a standard PET/CT scan and immediately after by the digital PET/CT scan, or vice versa. The investigators wish to determine if image quality is equivalent with the digital PET/CT scanner.

Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients undergoing digital PET/CT

Single arm prospective study of paired imaging studies. Patients who are referred to Nuclear Medicine and are scheduled to undergo imaging on the standard PET/CT will also have imaging performed on the digital PET/CT.

Group Type OTHER

Digital PET/CT scan

Intervention Type DIAGNOSTIC_TEST

The Division of Nuclear Medicine and Molecular Imaging at Stanford has installed the first ever GE-made digital PET/CT scanner worldwide. The investigators wish to determine if the digital PET/CT scanner offers equivalent image quality as the standard PET/CT scanner.

Interventions

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Digital PET/CT scan

The Division of Nuclear Medicine and Molecular Imaging at Stanford has installed the first ever GE-made digital PET/CT scanner worldwide. The investigators wish to determine if the digital PET/CT scanner offers equivalent image quality as the standard PET/CT scanner.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patient is ≥ 18 years old at the time of the scan
* Patient provides written informed consent
* Patient is referred for standard (F18 FDG; F18 NaF; Ga68 DOTATATE) or research (68Ga PSMA or 68Ga RM2) PET/CT
* Patient is capable of complying with study procedures
* Patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both PET/CT)

Exclusion Criteria

* Patient is pregnant or nursing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Andrei Iagaru

Chief of the Division of Nuclear Medicine and Molecular Imaging

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrei Iagaru, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

References

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Duan H, Baratto L, Hatami N, Liang T, Mari Aparici C, Davidzon GA, Iagaru A. 68Ga-PSMA11 PET/CT for biochemically recurrent prostate cancer: Influence of dual-time and PMT- vs SiPM-based detectors. Transl Oncol. 2022 Jan;15(1):101293. doi: 10.1016/j.tranon.2021.101293. Epub 2021 Nov 22.

Reference Type RESULT
PMID: 34823095 (View on PubMed)

Baratto L, Toriihara A, Hatami N, Aparici CM, Davidzon G, Levin CS, Iagaru A. Results of a Prospective Trial to Compare 68Ga-DOTA-TATE with SiPM-Based PET/CT vs. Conventional PET/CT in Patients with Neuroendocrine Tumors. Diagnostics (Basel). 2021 May 30;11(6):992. doi: 10.3390/diagnostics11060992.

Reference Type RESULT
PMID: 34070751 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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IRB Protocol: 39329

Identifier Type: -

Identifier Source: org_study_id

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