A Phase 1/2 interventional study of 68Ga-DOTATATE PET/CT in Osteomalacia, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-30.
Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Diagnostic
The researchers are trying to evaluate a newer imaging technique (Ga-DOTATATE PET/CT) to see if it is more sensitive to localize the source of the hormone, which has caused the low phosphate levels.
Subjects will be contacted (phone script attached) to inform them of the study and the imaging modality. The first 10 patients that agree to participate in the study will be asked to present to the Mayo Clinic where they can provide a written consent and perform the imaging study.
Enrolled subjects will be evaluated in the clinical practice prior to having 68Ga-DOTATATE PET/CT imaging performed. The treating endocrinologist will be informed of the imaging results and will review the results with the subject using a follow-up visit or phone call; when a tumor is localized, the endocrinologist will discuss appropriate management options.
Subjects will be follow for one year post 68Ga-DOTATATE PET/CT.
34 studies on the registry are indexed under Osteomalacia; 3 are open to participants now.
This study's enrollment of 18 is above the median of 15 across 17 interventional studies indexed under Osteomalacia.
Browse Osteomalacia studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects will undergo imaging by 68Ga-DOTATATE PET/CT
Combination Product: 68Ga-DOTATATE PET/CT
Gallium-68 Dotatate, a radioactive imaging agent, is injected into a vein. Subjects will rest for approximately 50 minutes, after which approximately a 30 minute image of subjects body will be completed via PET/CT scan.
Number of Participants With Positive Localization of Phosphaturic Mesenchymal Tumors (PMTs)
68Ga-DOTATATE PET maximum intensity projection images will be analyzed to evaluate for the localization of phosphaturic mesenchymal tumors (PMTs).
Time frame: One year
| Milestone | 68Ga-DOTATATE PET/CT |
|---|---|
| Started | 18 |
| Completed | 18 |
| Not completed | 0 |
68Ga-DOTATATE PET maximum intensity projection images will be analyzed to evaluate for the localization of phosphaturic mesenchymal tumors (PMTs).
| Participants | 68Ga-DOTATATE PET/CT |
|---|---|
| Number of Participants With Positive Localization of Phosphaturic Mesenchymal Tumors (PMTs) | 15 |
Collected over Participants were monitored from administration of the radioactive imaging agent until approximately 30 minutes after PET/CT scan, for a total of approximately 2 hours.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 68Ga-DOTATATE PET/CT | 0/18 (0%) | 0/18 (0%) | 0/18 (0%) |
| Age, Categorical(Participants) | 68Ga-DOTATATE PET/CT |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 5 |
| Age, Continuous(years) | 68Ga-DOTATATE PET/CT |
|---|---|
| Mean | 52.6 ± 13.4 |
| Sex: Female, Male(Participants) | 68Ga-DOTATATE PET/CT |
|---|---|
| Female | 7 |
| Male | 11 |
| Race (NIH/OMB)(Participants) | 68Ga-DOTATATE PET/CT |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 16 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2019 to primary completion in Oct 2023, 57 months.
Results were first posted in Apr 2025, 1 year 5 months after primary completion.
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