A Study of a New PET Scanner in People With Cancer

Quality Improvement Study of a New Generation of Whole Body PET Scanners

The researchers are doing this study to test the capabilities of a new total-body PET scanner called the Biograph Vision Quadra. The researchers want to learn whether this scanner can produce better PET/CT images and provide more useful imaging information than standard PET/CT scanners.

Study Overview

Detailed Description

This protocol is a quality improvement protocol intended to explore and capitalize on the advanced performance characteristics of a new total body PET scanner; the Biograph Vision Quadra manufactured by Siemens Healthineers.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: John Humm, PhD
  • Phone Number: 212-639-7367

Study Locations

    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge (Consent Only)
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-8001
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (Consent only)
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-8001
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (Consent only )
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-8001
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk-Commack (Consent only)
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-8001
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (Consent only)
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-8001
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-8001
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (Consent Only)
        • Contact:
          • Heiko Schoder, MD
          • Phone Number: 212-639-8001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any MSKCC patients with histologically confirmed cancer, who will be scheduled to receive a planned PET-CT scan at the MSK main campus may be enrolled in this image evaluation and improvement study. Potential patients will be identified by a member of the patient's treatment team at MSKCC, who will introduce the study to them.

Description

Inclusion Criteria:

Eligibility Criteria for objective #1:

  • Patients with histologically-confirmed non-small cell lung carcinoma (NSCLC) with a single or multiple lung nodules.
  • Patients who are undergoing a planned PET-CT scan at main campus of MSK.
  • Patients must be ≥ 18 years old

Eligibility Criteria for objective #2:

  • Patients with disease within the chest, abdomen or pelvis, who could benefit from visualizing the pharmacokinetics of radiotracer uptake within all disease sites simultaneously.
  • Patients with metastatic prostate or head and neck cancer.
  • Patients with prostate cancer who are undergoing a 68Ga-PSMA or 18F-FDG scan at the main campus of MSK.
  • Patients with head and neck cancer who are undergoing a 18F-FDG scan at the main campus of MSK
  • Patients must be ≥ 18 years old

Eligibility Criteria for objective #3:

  • Patients with histologically-confirmed cancer from all three groups (lung cancer, head and neck cancer, prostate cancer).
  • Patients who are undergoing an 68Ga-PSMA or 18F-FDG or an [18F]-fluormisonidazole PET-CT scan at the main campus of MSK.
  • Patients willing to return to the MITS clinc for late imaging session between 2 to 6 hours after the PET radiotracer injection. (In current practice, FDG is imaged between 1 and 1.5 hours post injection, and FMISO is imaged between 2.5 and 3 hours post injection)
  • Patients must be ≥ 18 years old

Exclusion Criteria:

  • Patients who suffer from claustrophobia.
  • Women who are pregnant or breast-feeding.
  • Patients < 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with lung, head and neck, and prostate cancer
The only investigational aspect of this quality improvement protocol is the acquisition of additional PET/CT imaging data (e.g. breath-hold, dynamic, and/or delayed acquisition) in patients who are already scheduled to receive a PET/CT scan as part of standard of care or under an existing clinical trial.
new total-body PET scanner, 1 or 2 additional scans with the Biograph Vision Quadra scanner.
Scheduled PET/CT scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
image quality
Time Frame: 3 years
Detection of any new/additional lesions on the delayed scan will be recorded using standard clinical interpretation.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Heiko Schoder, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

July 1, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 8, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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