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NCT04105634 · ClinicalTrials.gov registry record · Early Phase 1

Molecular Imaging of the Underlying Mechanism of Cardiotoxicity in Patients With Light Chain Amyloidosis Using PET/CT

A Early Phase 1 study, sponsored by University of Pennsylvania.

Terminated
Registry status
Early Phase 1
Development phase
3
Enrollment target

NCT04105634: Clinical Trial Early Phase 1 study, sponsored by University of Pennsylvania.

NCT04105634 is a Early Phase 1 study that was terminated before completion, run by University of Pennsylvania. The registered enrollment target is 3 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04105634, a Early Phase 1 study, was terminated before completion, sponsored by University of Pennsylvania.

TERMINATED
Registry status
Early Phase 1
Development phase
3 participants
Enrollment target

Study Summary

The research study is being conducted to test how two different types of Positron Emission Tomography (PET/CT) scans could be used to image a type of heart disorder called amyloidosis (AL). There will be two groups in the study. One group will have PET/CT scans using an imaging drug called 18F-NOS and the other group will have PET/CT scans using a drug called Florbetaben. subject will be assigned to one of the groups when she/he agrees to be in the study.

Primary Outcome

Measure uptake of \[18F\]NOS and Florbetaben in patients with AL before and \~4 months (2 +/- weeks) after starting standard therapy and describe the distributions of uptake values at each time point. Compute post-/pre-treatment fold change in \[18F\]NOS and Florbetaben uptake and describe its distribution.

Interventions

  • DRUG Florbetaben
  • DRUG FNOS

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2019-10-01
Est. Completion 2024-10-14
Phase Early Phase 1
University of Pennsylvania

1,423 total trials

Why NCT04105634 stopped before completion

NCT04105634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Florbetaben is the first listed.

NCT04105634 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04105634 about?

NCT04105634 is a clinical study titled "Molecular Imaging of the Underlying Mechanism of Cardiotoxicity in Patients With Light Chain Amyloidosis Using PET/CT". The research study is being conducted to test how two different types of Positron Emission Tomography (PET/CT) scans could be used to image a type of heart disorder called amyloidosis (AL). There will be two groups in the study. One group will have PET/CT scans using an imaging drug called 18F-NOS a...

What is the current status of trial NCT04105634?

This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 3 participants. The study started on 2019-10-01. Estimated completion is 2024-10-14.

What interventions are being tested in trial NCT04105634?

The interventions under investigation include: Florbetaben (DRUG), FNOS (DRUG).

Who is sponsoring clinical trial NCT04105634?

This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04105634's enrollment target sits among peer trials

3 1948th of 2000 higher than 28 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early 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 NCT04105634, the US trial registry maintained by the National Library of Medicine. NCT04105634 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.