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New treatment option for Bone Metastases
Official title Simulation-Free, Single-Fraction Palliative Radiation Therapy for Treatment of Bone Metastases
ClinicalTrials.gov ID: NCT07202273
What this study is testing
- What it's testing
- The goal of this study is to provide proof that patients can be treated with simulation-free, single-fraction palliative radiation therapy with a single in-person visit.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant aged ≥ 18 years.
- Diagnosis of any cancer with one to two painful and treatable metastatic bone lesions.
- Bone metastases are causing pain or instability in the opinion of the treating investigator.
- Amenable to single fraction radiation therapy per the discretion of the treating physician.
- CT collected within 60 days of registration with adequate visualization of target site as determined by the treating investigator.
You likely can't join if
- Evidence of spinal cord compression caused by the bone metastases to be treated.
- Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety...
- Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give...
- Participants taking prohibited medications as described in Section 6.7.1.
See the full eligibility criteria
- Participant aged ≥ 18 years.
- Diagnosis of any cancer with one to two painful and treatable metastatic bone lesions.
- Bone metastases are causing pain or instability in the opinion of the treating investigator.
- Amenable to single fraction radiation therapy per the discretion of the treating physician.
- CT collected within 60 days of registration with adequate visualization of target site as determined by the treating investigator.
- ECOG Performance Status ≤ 2.
- Participants must adhere to the following sex and contraceptive/barrier requirements:
- If participant is of childbearing potential, they must have a negative pregnancy test ≤ 14 days before the planned date of radiation therapy. This may be completed on the day of radiation if results from the pregnancy...
- For participants of non-child bearing potential: The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
- \< 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution ---≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses \>1 year ago; or
- Had chemotherapy-induced menopause with last menses \>1 year ago
- Participants of childbearing potential and participants with a sexual partner of childbearing potential must agree to use a highly effective method of contraception.
- Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.
- Evidence of spinal cord compression caused by the bone metastases to be treated.
- Any other condition that would, in the Investigator's judgment, contraindicate the participant's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Medical, psychiatric, cognitive, or other conditions that may compromise the participant's ability to understand the participant information, give informed consent, comply with the study protocol or complete the study.
- Participants taking prohibited medications as described in Section 6.7.1.
The study team makes the final eligibility decision.
Where it's taking place
- Salt Lake City, Utah, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Salt Lake City, Utah, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.