TriangleNCT05105087 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment. Perflubutane Microbubble: Given subdermally Contrast-Enhanced Ultrasound: Undergo ultrasound
- id
- FG000
- title
- Diagnostic (Perflubutane Microbubble, Ultrasound)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Ineligible for surgery due to advanced disease
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 9
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 5
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 4
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Screening assessments were performed within 4 weeks prior to the administration of Sonazoid. A full demographic profile, known drug allergies or intolerances, and a review of the subject's medical/surgical history were recorded. 9 participants received CEUS. 5 completed both CEUS and surgery with pathology and were analyzed. 2 were ineligible for surgery (advanced disease), and 2 withdrew consent prior to surgery; thus no outcome data were available for these 4 participants.
- recruitment Details
- This was a single-site, open-label, non-randomized pilot study conducted at Thomas Jefferson University (TJU), Sidney Kimmel Cancer Center, Philadelphia, PA. Subject recruitment was expected to last 24 months, beginning in April 2022 and ending in November 2023. Recruitment was conducted from the patient population of the Department of Gynecology Oncology at TJU. Eligible participants were identified by surgical co-investigators from their existing patient population.
Complete source fields
- groups
- description
- Patients receive perflubutane microbubble injections subdermally and then undergo ultrasound over 30 minutes before standard of care cancer treatment. Perflubutane Microbubble: Given subdermally Contrast-Enhanced Ultrasound: Undergo ultrasound
- id
- FG000
- title
- Diagnostic (Perflubutane Microbubble, Ultrasound)
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 2
- type
- Ineligible for surgery due to advanced disease
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 9
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 5
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 4
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- Screening assessments were performed within 4 weeks prior to the administration of Sonazoid. A full demographic profile, known drug allergies or intolerances, and a review of the subject's medical/surgical history were recorded. 9 participants received CEUS. 5 completed both CEUS and surgery with pathology and were analyzed. 2 were ineligible for surgery (advanced disease), and 2 withdrew consent prior to surgery; thus no outcome data were available for these 4 participants.
- recruitment Details
- This was a single-site, open-label, non-randomized pilot study conducted at Thomas Jefferson University (TJU), Sidney Kimmel Cancer Center, Philadelphia, PA. Subject recruitment was expected to last 24 months, beginning in April 2022 and ending in November 2023. Recruitment was conducted from the patient population of the Department of Gynecology Oncology at TJU. Eligible participants were identified by surgical co-investigators from their existing patient population.
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Preserved source evidence · Not medical advice