Pilot Study Assessment of Bone Mineral Density Changes During Treatment With Anti-PD-1 Immunotherapy Agents
Condition: Breast Cancer (Triple Negative Breast Cancer (TNBC)), Renal Cell Carcinoma (Kidney Cancer), Melanoma (Skin Cancer), Non-Small Cell Lung Cancer, MSI-H/dMMR Rectal Cancer, Squamous Cell Carcinoma Mouth, Invasive Mammary Carcinoma, Classic Hodgkin Lymphoma
Study Type: Interventional
Clinical Trials Identifier NCT 8-digits: NCT07555210
Sponsor: Jessica Mezzanotte Sharpe
Eligibility:
- Age: minimum 18 Years maximum N/A
- Gender: All
Inclusion Criteria:
- Age ≥ 18 years.
- Patients planning to start or within the first four weeks of treatment with anti-PD-1 immune checkpoint inhibitor therapy either alone or in combination with chemotherapy for curative intent for a known cancer diagnosis (use of immunotherapy must be FDA-approved and not experimental).
- Life expectancy of at least 12 months per the discretion of the treating physician.
Exclusion Criteria:
- Patients ineligible for anti-PD-1 therapy.
- Patients with metastatic disease.
- Patients planning treatment with dual immune checkpoint inhibitor therapy.
- Bony fractures in the pelvis, bilateral hips/femurs, thoracic spine, or lumbar spine.
- Known osteoporosis or osteopenia.
- Planned or previous treatment with denosumab, zoledronic acid, or other bisphosphonate therapy in the last six months.
- Parathyroid gland disorders, rheumatoid arthritis (unless well-controlled off active biologic therapy without chronic steroid use), CKD stage IV/V, or ESRD.
- Inability to comply with study procedures.
- Inability to lie flat for 20-25 minutes during an imaging session.
- Pregnant or breastfeeding patients.
- Medical or psychiatric co-morbidities that, in the opinion of the treating physician, would prevent the patient from successfully participating in the study.
View trial on ClinicalTrials.gov