Recruiting

Radiation

Sponsor:

David Palma

Code:

NCT06156800

Conditions

Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

When a doctor suspects cancer, often a biopsy is taken for testing to confirm if cancer is present. Usually, doctors would wait for the results of a biopsy before delivering radiation, but this may lead to a patient having to wait for a treatment that he or she urgently needs.

With long wait times for biopsies in Canada, this may lead to symptoms and risks of complications from cancer in the meantime. Therefore, this study is being done to answer the following question: Is it safe and feasible to deliver radiation before obtaining a biopsy in a carefully selected group of patients who urgently need radiation treatment.

Conditions

Cancer

Study ID

NCT06156800

Start date

Apr 19, 2024

Status verified date

Jul, 2025

Completion date

Jul 1, 2027

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age 18 years or older
  • Willing to provide informed consent
  • Palliative treatment intent: either metastatic or incurable locally advanced disease
  • Tissue diagnosis is not required for determination of dose/fractionation scheme
  • Recent cross-sectional imaging \[for example - Computed Tomography (CT), Magnetic Resonance Imaging (MRI), Positron Emission Tomography/Computed Tomography (PET/CT)\] of the area to be treated, done within the past 3 months
  • Treating physician considers the pre-test probability of cancer greater than 95 percent based on clinical judgement and radiological findings.
  • The patient has at least 1 site of cancer amenable to biopsy

  • As per standard practices, if the radiation oncologist will be radiating the only site available to biopsy, they should proceed with caution. Participants should only be enrolled on trial if the risk of harm from delaying Radiation Therapy (RT) significantly outweighs the risks of possible non-diagnostic tissue. If the participant may potentially be eligible for systemic therapy, the treating radiation oncologist should consult a medical oncologist for an opinion regarding the risks of non-diagnostic molecular testing. The weighing of these priorities should be thoroughly discussed with the participant and the discussion should be documented.
  • Reasons for radiating a participant with a single lesion prior to biopsy include:

  • Spinal cord compression (actual or impending) and inoperable
  • Brain metastasis with significant symptoms or neurologic deficits and inoperable
  • Other lesions causing neurologic deficit
  • Pulmonary lesion causing or threatening lung obstruction
  • Uncontrolled bleeding (including hemoptysis and hematuria)
  • Superior vena cava obstruction (actual or impending)
  • Limited upside to molecular testing, as determined by the medical oncologist (for example - participant unfit for available systemic therapies, limited options for systemic therapy)
  • Radiation is considered urgent (for example - participant should receive radiation prior to biopsy date) o Urgent indications may include but are not limited to the reasons listed previously, as well as the following:

  • Painful metastases or primary lesion not adequately responding to analgesia
  • Symptomatic brain metastases
  • Bleeding
  • Impending pathologic fracture

Exclusion Criteria:

  • Participant is potentially eligible for curative treatment
  • Clinical suspicion of lymphoma o Some features may be suggestive of lymphoma, including fever or night sweats (for example - B symptoms excluding weight loss), or imaging showing well-defined, homogenous lymphadenopathy. These findings are not exclusion criteria specifically, but should be considered by the clinician in formulating their differential diagnosis.

Study Design

Enrollment

48 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Percent of Inappropriate Use of Radiation Therapy in Participants with Urgent Indications Treated Prior to Biopsy Results [ Time Frame: 2 weeks after biopsy results ]

Central Contacts and Locations

Central contacts

David Palma, MD

519-685-8650David.Palma@lhsc.on.ca

Sympascho Young, MD

Sympascho.Young@lhsc.on.ca

Locations

London Regional Cancer Program, London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5W9

Contacts

David Palma, MD

519-685-8650David.Palma@lhsc.on.ca

More Information

Sponsor

David Palma

Last update posted

Jul 25, 2025

Last verified

Jul, 2025

Keywords

  • Palliative Irradiation
  • Biopsy
  • Radiation Therapy
  • Pathology

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Palma on 2025-07-25.