deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT00674440

Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism

Localization of Focal Forms of Hyperinsulinism of Infancy With 18F-labeled L-fluoro-DOPA PET Scan

Sponsor: Children's Hospital of Philadelphia

Interventions F-DOPA PET scan
Updated 11 times since 2017 Last updated: Oct 11, 2022 Started: Dec 31, 2004 Primary completion: Dec 31, 2008 Completion: Jan 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on CHI and Congenital Hyperinsulinism, this trial is completed. The trial is conducted by Children's Hospital of Philadelphia and has accumulated 11 data snapshots since 2004. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.

For children with congenital hyperinsulinism (CHI), low blood sugar is caused by cells in the pancreas that release too much insulin. Some children with CHI have these cells throughout their pancreas; others have them located in specific areas of the pancreas. Children who have them located in specific areas of the pancreas may be cured with surgery. F-DOPA is a radioactive drug that may go to these very cells. F-DOPA can also be used for positron emission tomography (or PET), an imaging technique used in nuclear medicine departments. In this study, researchers will test the possibility of using PET with F-DOPA in the diagnosis of children with hyperinsulinism.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Mar 2018 · 13 months · monthly snapshotActive Not Recruiting~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotCompleted~Jun 2018 – ~Mar 2020 · 21 months · monthly snapshotCompleted~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshotCompleted~Jan 2021 – ~Apr 2022 · 15 months · monthly snapshotCompleted~Apr 2022 – ~Dec 2022 · 8 months · monthly snapshotCompleted~Dec 2022 – ~Jul 2024 · 19 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Dec 2022 — Jul 2024 [monthly]

    Completed PHASE2

  5. Apr 2022 — Dec 2022 [monthly]

    Completed PHASE2

Show 6 earlier versions
  1. Jan 2021 — Apr 2022 [monthly]

    Completed PHASE2

  2. Mar 2020 — Jan 2021 [monthly]

    Completed PHASE2

  3. Jun 2018 — Mar 2020 [monthly]

    Completed PHASE2

  4. Mar 2018 — Jun 2018 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  5. Feb 2017 — Mar 2018 [monthly]

    Active Not Recruiting PHASE2

  6. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE2

    First recorded

Dec 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Children's Hospital of Philadelphia
  • University of Pennsylvania
Data source: Children's Hospital of Philadelphia

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations