Clinical trial NCT03085238: Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
Official title: Safety and Performance of Metastatic Tumor Cell Trap Device in Patients With Advanced Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ovarian Cancer Stage IIIC
Ovarian Cancer Stage IV
Lead sponsor: MTrap, Inc.
Sponsor class: INDUSTRY
Collaborators: name: MedPass International
First posted: 2017-03-21
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-center, non-blinded, single-arm study
Primary purpose: TREATMENT

Brief summary: M-Trap is an implantable medical device designed to capture disseminated tumor cells (DTCs). It is intended for use in advanced-stage ovarian cancer patients. The study objective is to assess the safety and the performance of the M-Trap device.


Eligibility criteria: Inclusion Criteria:

1. Is a female ≥18 years old.
2. Presents with a diagnosis of Stage IIIC ovarian cancer.
3. Presents with high-grade serous carcinoma.
4. Has one of the following:

   1. Visible residual tumor ≤1 cm after primary tumor debulking surgery.
   2. Three cycles of neoadjuvant chemotherapy and complete resection after interval tumor debulking surgery.
   3. Three cycles of neoadjuvant chemotherapy and visible residual tumor ≤1 cm after interval tumor debulking surgery.
5. ECOG performance status of 0 or 1.
6. Is willing to comply with required follow-up study visits.
7. Is willing and able to provide written informed consent.

Exclusion Criteria:

1. Has a life expectancy of \<3 months.
2. Is pregnant, as confirmed through a blood test prior to any study procedure, planning on becoming pregnant during the study, or is lactating.
3. Will be receiving intraperitoneal chemotherapy.
4. Has undergone prior treatment with abdominal and/or pelvic radiotherapy.
5. Has significant active concurrent medical illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
6. Presence of central nervous system or cerebral metastases.
7. Recurrent ovarian cancer.
8. Complete resection with no residual tumor after primary tumor debulking surgery.
9. Suboptimal resection with \>1 cm residual tumor after primary or interval tumor debulking surgery.
10. Is simultaneously enrolled in another investigational study.
11. Has a history of cancer within 5 years other than in-situ uterine cervix cancer or non-melanoma skin cancer.
12. Has a known hypersensitivity to carboplatin or paclitaxel.
13. Is concurrently using other antineoplastic agents.

Primary outcomes:
measure: Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
timeFrame: 6 months
measure: Safety: Number of Participants With Freedom From Device and Procedure-related Major Adverse Events
timeFrame: 30 days
measure: Performance: Number of Participants With Histological Evidence of Tumor Cell Capture
timeFrame: Time of device removal, an average of 13.3 months
Secondary outcomes:
measure: Safety: Number of Participants With Device-related Long-term Adverse Event Reporting
timeFrame: 18 months
measure: Safety: Number of Participants With Procedure-related Long-term Adverse Event Reporting
timeFrame: 18 months
measure: Performance: Disease Focalization Score Categorized as I, I or II, I or II or III, and I or II or III or IV by Recurrence Status
timeFrame: Time of recurrence, an average of 14.5 months
Other outcomes:
measure: Number of Devices Implanted
timeFrame: Immediately post-procedure
measure: Disease Focalization Score by Recurrence Status
timeFrame: Time of recurrence, an average of 14.5 months
measure: Number of Participants With Reasons for Device Removal
timeFrame: Time of device removal, an average of 13.3 months
Locations:
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Castelló
country: Spain
facility: Castellon University General Hospital
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital La Paz Madrid
city: Santiago de Compostela
country: Spain
facility: Complexo Hospitalario Universitario de Santiago
city: Valencia
country: Spain
facility: Valencia-Hospital General
city: Valencia
country: Spain
facility: Hospital Universitrio y Politècnico La Fe
Study officials:
affiliation: Hospital Vall d'Hebron
name: Antonio Gil-Moreno, MD
role: PRINCIPAL_INVESTIGATOR
References: