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NCT07664397 · ClinicalTrials.gov registry record · Phase 1

Imaging Study of [89Zr]DFO-YS5 for Cancer Detection

A Phase 1 study, sponsored by Robert Flavell, MD, PhD.

Not yet
Registry status
Phase 1
Development phase
40
Enrollment target

NCT07664397: Clinical Trial Phase 1 study, sponsored by Robert Flavell, MD, PhD.

NCT07664397 is a Phase 1 study that has not yet begun recruiting, run by Robert Flavell, MD, PhD. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07664397, a Phase 1 study, has not yet begun recruiting, sponsored by Robert Flavell, MD, PhD.

NOT YET RECRUITING
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study Summary

This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\[89Zr\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.

Primary Outcome

A volume of interest (VOI) will be placed around each lesion, and the calculated maximum standard uptake value (SUVmax) will be recorded for each lesion. Adjusted SUVmax data will then be averaged across up to 15 lesions within a given patient (SUVmax-avg) at each time point. In order to avoid clustering effects, analyses will be limited to the five largest osseous metastases, five largest lymph node metastases, and five largest visceral/soft tissue metastases. Metastatic lesion location, size (

Interventions

  • DRUG [89Zr]DFO-YS5
  • PROCEDURE Positron Emission Tomography (PET)-Magnetic resonance imaging (MRI)
  • PROCEDURE Positron Emission Tomography (PET)-Computerized tomography (CT)

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2026-08-01
Est. Completion 2029-09-30
Phase Phase 1
Robert Flavell, MD, PhD

5 total trials

What is known before NCT07664397 opens enrollment

NCT07664397 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 3 interventions - of which [89Zr]DFO-YS5 is the first listed.

NCT07664397 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07664397 about?

NCT07664397 is a clinical study titled "Imaging Study of [89Zr]DFO-YS5 for Cancer Detection". This is a single-center, pilot, PET-imaging study of the novel radiotracer 89Zirconium-89 DFO conjugated to the YS5 monoclonal antibody (\[89Zr\]DFO-YS5) in participants with nerve sheath tumor, bladder cancer, or advanced solid tumor neoplasms.

What is the current status of trial NCT07664397?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2026-08-01. Estimated completion is 2029-09-30.

What interventions are being tested in trial NCT07664397?

The interventions under investigation include: [89Zr]DFO-YS5 (DRUG), Positron Emission Tomography (PET)-Magnetic resonance imaging (MRI) (PROCEDURE), Positron Emission Tomography (PET)-Computerized tomography (CT) (PROCEDURE).

Who is sponsoring clinical trial NCT07664397?

This trial is sponsored by Robert Flavell, MD, PhD, which has 5 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07664397's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07664397, the US trial registry maintained by the National Library of Medicine. NCT07664397 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.