Status:
COMPLETED
Catheterization to Locate Mesenchymal Tumors in Patients With Tumor-Induced Osteomalacia or Oncogenic Osteomalacia
Lead Sponsor:
National Institute of Dental and Craniofacial Research (NIDCR)
Conditions:
Osteomalacia
Neoplasms
Eligibility:
All Genders
8-100 years
Brief Summary
This study will use a procedure called selective venous catheterization in patients with tumor-induced osteomalacia (TIO) or oncogenic osteomalacia (OOM) to try to locate very small tumors that produc...
Detailed Description
Phosphaturic mesenchymal tumors elaborate phosphate lowering factors (phosphatonins) which lead to tumor induced osteomalacia/osteogenic osteomalacia (TIO/OOM). Patients with TIO/OOM suffer years of s...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Patients must have the clinical diagnosis of TIO/OOM to be considered for enrollment in this study. The diagnosis will be based upon a clinical history including some or all of: rickets (children), pathological fractures, bone pain, muscle weakness, low serum phosphorus with concomitant inappropriately high urine phosphorus, low or inappropriately low-normal serum vitamin 1,25 (OH)(2)-vitamin D3, and an elevated FGF-23 level in the absence of a family history of a phosphate wasting syndrome. Along with the clinical symptoms listed above, the patient must have undergone routine clinical imaging.
- Inclusion will be limited to all patients in whom a likely lesion was not localized by imaging, plus five patients for whom a likely lesion has been identified by imaging. Patients with a likely lesion identified will serve as positive controls.
- Patients must be able to give informed consent.
- EXCLUSION CRITERIA:
- Patients with co-morbidities that would increase the risk of selective venous catheterization will be excluded from the study. This includes but is not limited to medical conditions such as: poorly controlled diabetes, renal insufficiency, chronic obstructive pulmonary disease, anemia, hypertension, clotting disorders, etc.
- Pregnancy is a contraindication to this venous catheterization procedure. A serum Beta-Hcg will be required for all eligible women of childbearing age unless documentation of a hysterectomy or other condition that makes pregnancy impossible is provided.
- Inability or unwillingness to give informed consent will exclude patients from this study. Female patients who will not allow pregnancy testing and will not provide documentation indicating a medical condition that makes pregnancy impossible will not be eligible for this study.
Exclusion
Key Trial Info
Start Date :
December 15 2004
Trial Type :
OBSERVATIONAL
End Date :
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00099762
Start Date
December 15 2004
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892