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New treatment option for Lung Carcinoma
Official title Stereotactic Body Radiation Therapy Planning With Artificial Intelligence-Directed Dose Recommendation for Treatment of Primary or Metastatic Lung Tumors, RAD-AI Study
ClinicalTrials.gov ID: NCT05802186
What this study is testing
- What it's testing
- This phase II trial tests the effectiveness and safety of artificial intelligence (AI) to determine dose recommendation during stereotactic body radiation therapy (SBRT) planning in patients with primary lung cancer or tumors that has spread from another primary site to the lung (metastatic). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision.
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
- Patients with radiographic findings consistent with lung cancer or solitary or oligometastatic disease in the lung. Most patients will have primary...
- Patients must have radiographically measurable or evaluable disease per RECIST v. 1.1.
- Patients must be age \>= 18 years.
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patients of child-bearing potential (POCBP) must have a negative urine or serum pregnancy test prior to registration on study.
You likely can't join if
- Patients who have had prior radiotherapy with radiation field overlap.
- For primary lung cancers, patients with ground glass opacities without a solid component will be excluded.
- Patients who have not recovered from adverse events confined to the thorax (i.e. pneumonitis, bronchial insufficiency, bronchial hemorrhage...
- Patients who are receiving any other concurrent investigational agents or genotoxic chemotherapy for cancer treatment.
- Note: Patients receiving targeted therapies are permitted to enroll on the study. However, patients must pause treatment with targeted therapy 3 days...
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works...
See the full eligibility criteria
- Patients with radiographic findings consistent with lung cancer or solitary or oligometastatic disease in the lung. Most patients will have primary non-small cell lung cancer. For primary lung cancers, we include...
- Patients must have radiographically measurable or evaluable disease per RECIST v. 1.1.
- Patients must be age \>= 18 years.
- Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Patients of child-bearing potential (POCBP) must have a negative urine or serum pregnancy test prior to registration on study.
- NOTE: A POCBP is any person with an egg-producing reproductive tract (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)
- Radiation therapy is known to be teratogenic. Patients of child-bearing potential (POCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from time of informed consent...
- Patients must have the ability to understand and the willingness to sign a written informed consent document. Informed consent must be signed prior to registration on study.
- Patients who have had prior radiotherapy with radiation field overlap.
- For primary lung cancers, patients with ground glass opacities without a solid component will be excluded.
- Patients who have not recovered from adverse events confined to the thorax (i.e. pneumonitis, bronchial insufficiency, bronchial hemorrhage, esophagitis) due to prior anticancer therapy (i.e., have residual toxicities...
- Patients who are receiving any other concurrent investigational agents or genotoxic chemotherapy for cancer treatment.
- Note: Patients receiving targeted therapies are permitted to enroll on the study. However, patients must pause treatment with targeted therapy 3 days prior to SBRT and restart medication at least 2 days after SBRT...
- Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen. Patients who have an...
- Ongoing or active infection requiring systemic treatment
- Unstable angina pectoris
- Stage 3 or greater idiopathic pulmonary fibrosis
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
- Female patients who are pregnant or nursing. Pregnant women are excluded from this study because radiation therapy has teratogenic or abortifacient effects.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, 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 Chicago, Illinois, 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.