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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
Must not have
Subjects in whom tumor localization and successful resection has already occurred.
Subjects diagnosed with heritable hypophosphatemic rickets/osteomalacia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My tumor was successfully located and removed.
Select...
I have been diagnosed with a genetic form of rickets or osteomalacia.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
68Ga-DOTATATE PET Positive Maximum Intensity Projection

Side effects data

From 2019 Phase 4 trial • 15 Patients • NCT03549598
7%
Nausea
100%
80%
60%
40%
20%
0%
Study treatment Arm
68Ga-DOTATATE PET/CT
18FDG PET/CT
13NH3 PET/CT"

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,362 Previous Clinical Trials
3,065,941 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
Peter Tebben, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
600 Total Patients Enrolled
Jad Sfeir, 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
~3 spots leftby Dec 2025
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