Phase 1 Ovarian Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You have a suspected or confirmed diagnosis of advanced ovarian, fallopian tube, or peritoneal cancer (stage III or IV, meaning the cancer has spread outside the pelvis).
• You fall into one of these four groups:
  • You are newly diagnosed (or suspected) and your doctor has recommended surgery to remove the cancer, but you have not had surgery yet.
  • You are newly diagnosed and your doctor needs to perform a keyhole (laparoscopic) procedure to decide whether surgery or chemotherapy first is the right approach for you.
  • Your ovarian cancer has come back and your doctor is considering surgery to remove it or confirm the recurrence.
  • You have already had chemotherapy before surgery (called neoadjuvant chemotherapy) and your doctor has now recommended surgery, but you have not had it yet.
• You are 18 years of age or older.
• Your doctors (cancer surgeon and medical oncologist) consider you healthy enough to safely have both a needle procedure and your planned surgery.
• Your recent blood test results (taken within 14 days before the study procedure, or 7 days if you are in group 4 above) meet certain safety levels for blood counts and clotting ability.
• If you could become pregnant, you must have a negative pregnancy test before joining.
• You have had a CT scan of your abdomen and pelvis within the past 4 weeks that shows enough detail about your cancer and confirms a safe location for the study device to be placed and later removed during surgery.
• Your tumour is large enough for the study device to be safely placed inside it, without affecting the tissue needed for your diagnosis.
• The tumour where the device will be placed can be safely reached by a needle from outside the body, and can be removed during your planned surgery or keyhole procedure without significantly affecting the operation or your safety.
• You are willing and able to understand and sign a consent form.
• You are willing to have research genetic testing (of both your tumour and inherited genes) and agree to your anonymised genetic data being stored in a national health research database.

Who may not be able to join:

• You have a serious uncontrolled illness, such as an active infection, unstable heart condition, irregular heartbeat, or a mental health or personal situation that would make a biopsy or surgery unsafe.
• You are currently pregnant, due to the radiation involved in imaging and the potential risks of the needle procedure near the baby.
• You have a bleeding or clotting disorder that cannot be corrected and that increases the risk of a needle biopsy or surgery.
• You have significant health risk factors (such as a high risk of blood clots, stroke, or heart attack) that mean it would not be safe for you to stop blood-thinning medication before the procedure, according to standard medical guidelines. (Note: taking low-dose aspirin alone does not disqualify you.)

Important: Always verify eligibility with the trial site directly before applying.