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Ga-DOTATATE PET Imaging for Osteomalacia

Phase 1 & 2

Waitlist Available

Led By Matthew Drake, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults (18 years of age or older) seen at Mayo Clinic, Rochester for FGF23 mediated osteomalacia between 1/1/2000 and 1/30/2018 who provide informed consent to participate in the study.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one year

Awards & highlights

Study Summary

This trial is testing a new imaging technique to see if it can more accurately locate the source of a hormone that is causing low phosphate levels.

Who is the study for?

This trial is for adults over 18 who have been seen at Mayo Clinic, Rochester for FGF23 mediated osteomalacia between 2000 and 2018. Participants must consent to the study. It excludes prisoners, pregnant individuals, those with heritable forms of the condition or those who've already had successful tumor localization and resection.Check my eligibility

What is being tested?

The trial evaluates a new imaging technique called Ga-DOTATATE PET/CT to see if it's better at finding where the hormone causing low phosphate levels in patients with osteomalacia is coming from.See study design

What are the potential side effects?

Since this trial involves an imaging procedure rather than a drug treatment, side effects are minimal but may include discomfort during the scan or reactions related to contrast agents used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am an adult who was treated for FGF23 related bone disease at Mayo Clinic, Rochester between 2000 and 2018 and agree to join the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

68Ga-DOTATATE PET Positive Maximum Intensity Projection

Side effects data

From 2019 Phase 4 trial • 15 Patients • NCT03549598

Nausea

100%

80%

60%

40%

20%

Study treatment Arm

68Ga-DOTATATE PET/CT

18FDG PET/CT

13NH3 PET/CT"

Trial Design

1Treatment groups

Experimental Treatment

Group I: 68Ga-DOTATATE PET/CTExperimental Treatment1 Intervention

Subjects will undergo imaging by 68Ga-DOTATATE PET/CT

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

68Ga-DOTATATE PET/CT

2018

Completed Phase 4

~60

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor

3,205 Previous Clinical Trials

3,766,764 Total Patients Enrolled

Matthew Drake, MDPrincipal Investigator - Mayo Clinic

Mayo Clinic Hospital-Rochester Saint Marys Campus, Mayo Clinic Rochester

Umdnj-Robt W Johnson Medical Sch (Medical School)

Duke University Medical Center (Residency)

Stephen M Broski, MDPrincipal InvestigatorMayo Clinic

Media Library

68Ga-DOTATATE PET/CT Clinical Trial Eligibility Overview. Trial Name: NCT03736564 — Phase 1 & 2

Osteomalacia Research Study Groups: 68Ga-DOTATATE PET/CT

Osteomalacia Clinical Trial 2023: 68Ga-DOTATATE PET/CT Highlights & Side Effects. Trial Name: NCT03736564 — Phase 1 & 2

68Ga-DOTATATE PET/CT 2023 Treatment Timeline for Medical Study. Trial Name: NCT03736564 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there still opportunity to join this research endeavor?

"Affirmative. Clinicaltrials.gov provides evidence that this medical research is actively recruiting participants, who need to be sourced from 1 clinical centre. This trial was first posted on January 31st 2019 and last updated on June 28th 2022."

Answered by AI

How many participants have registered for this clinical research?

"Affirmative. According to the data provided by clinicaltrials.gov, this medical trial is actively recruiting participants. The study was first published on January 31st 2019 and has since been updated on June 28th 2022. Researchers need 10 individuals from 1 research centre for this project."

Answered by AI

Are there any precedent studies for 68Ga-DOTATATE PET/CT?

"Currently, there are 5 on-going clinical trials for 68Ga-DOTATATE PET/CT. 0 of these studies are at the Phase 3 level. As most of the work is located in Rochester, Minnesota there exist a total of 7 sites undertaking related research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia

Matthew Drake, MD 2019. "Ga-DOTATATE PET for Phosphaturic Mesenchymal Tumors in Patients With Tumor Induced Osteomalacia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03736564.