免费获得国外相关药品，最快 1 个工作日回馈药物信息
出境医 / 临床实验 / Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia (OVANOX)
Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia (OVANOX)
Study Description
Brief Summary:
The goal of this non-randomized prospective study is to use 18F-EF5-PET/CT imaging to identify and locate intraabdominal hypoxic ovarian cancer lesions. With targeted surgical sampling, precisely obtain hypoxic and potentially chemoresistant cancer tissue for our analyses and identify key molecular differences between hypoxic and non-hypoxic tumors within the same patient.
A portion of advanced stage EOC are inoperable at diagnosis and can be treated with neoadjuvant chemotherapy (NACT) before surgery. This approach offers a unique opportunity to study how hypoxic tumor areas respond to treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Epithelial Ovarian Cancer Fallopian Tube Cancer Peritoneal Carcinoma Hypoxia | Device: Imaging with 18F-EF5 PET/CT | Not Applicable |
Detailed Description:
MORE SPECIFIC AIMS
-
To validate the feasibility of PET-tracer EF5 in EOC imaging.
- Quantify the amount and exact locations of hypoxic tumors in EOC patients using herein developed protocol and tracers (18F-EF5 and 18F-FDG) in diagnostic and neoadjuvant settings.
- Measure the non-cancer related EF5 accumulation spots and establish the potential pitfalls in abdominal EF5 imaging
- Establish a method to verify hypoxic locations with 18F-EF5-PET/CT information during the operation.
- Develop and validate a model that predicts chemotherapy response based on functional imaging information.
- To reveal hypoxia related alterations in collected tissue samples (i.e. altered DNA damage repair, altered mitochondrial respiratory functioning, overexpression of hypoxia response elements etc)
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia |
| Actual Study Start Date : | March 9, 2017 |
| Estimated Primary Completion Date : | December 31, 2022 |
| Estimated Study Completion Date : | December 31, 2025 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Experimental: PDS
18F-EF5 PET/CT and 18F-FDG PET/CT scan prior to primary cytoreductive surgery and targeted sample collection during primary cytoreductive surgery
|
Device: Imaging with 18F-EF5 PET/CT
Both 18F-FDG PET/CT and 18F-EF5 PET/CT imaging are performed in 1) preoperative work-up to clarify the disease distribution, 2) before IDS to evaluate treatment response to NACT (IDS arm); targeted samples from hypoxic and non-hypoxic tumors are collected during surgery
Other Name: Collection of targeted samples during surgery
|
|
Experimental: IDS
18F-EF5 PET/CT and 18F-FDG PET/CT scans prior to diagnostic laparoscopy and after neoadjuvant chemotherapy before interval cytoreductive surgery . Targeted sample collection during diagnostic laparoscopy and interval cytoreductive surgery |
Device: Imaging with 18F-EF5 PET/CT
Both 18F-FDG PET/CT and 18F-EF5 PET/CT imaging are performed in 1) preoperative work-up to clarify the disease distribution, 2) before IDS to evaluate treatment response to NACT (IDS arm); targeted samples from hypoxic and non-hypoxic tumors are collected during surgery
Other Name: Collection of targeted samples during surgery
|
Outcome Measures
Primary Outcome Measures :
- 18F-EF5 maximum standardized uptake values (SUVmax) [ Time Frame: 2-3 years ]Tumor and musculus gluteus maximus SUVmax ratio ≥1.5 is considered to refer to hypoxia
Secondary Outcome Measures :
- Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue [ Time Frame: 2-3 years ]
- Disease-free survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]
Eligibility Criteria
| Ages Eligible for Study: | 18 Years to 79 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- newly diagnosed advanced epithelial ovarian, primary peritoneal or fallopian tube cancer.
- age 18-79 years
- informed concent
Exclusion Criteria:
- previous cancer
- pregnancy or nursing
Contacts and Locations
Contacts
| Contact: Maren Laasik, MD | +35823130000 | maren.laasik@utu.fi |
Locations
| Finland | |
| Turku University hospital | Recruiting |
| Turku, Finland, 20521 | |
| Contact: Sakari Hietanen, MD, PhD, Adj. prof +35823130000 sakari.hietanen@tyks.fi | |
| Principal Investigator: Johanna Hynninen, MD, PhD | |
| Sub-Investigator: Marko Seppänen, MD, PhD, Adj. prof. | |
| Sub-Investigator: Maren Laasik, MD | |
| Principal Investigator: Sakari Hietanen, MD, PhD, Adj. pr | |
Sponsors and Collaborators
Turku University Hospital
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | January 11, 2019 | ||||
| First Posted Date ICMJE | June 27, 2019 | ||||
| Last Update Posted Date | August 7, 2019 | ||||
| Actual Study Start Date ICMJE | March 9, 2017 | ||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
18F-EF5 maximum standardized uptake values (SUVmax) [ Time Frame: 2-3 years ] Tumor and musculus gluteus maximus SUVmax ratio ≥1.5 is considered to refer to hypoxia
|
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia | ||||
| Official Title ICMJE | Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia | ||||
| Brief Summary |
The goal of this non-randomized prospective study is to use 18F-EF5-PET/CT imaging to identify and locate intraabdominal hypoxic ovarian cancer lesions. With targeted surgical sampling, precisely obtain hypoxic and potentially chemoresistant cancer tissue for our analyses and identify key molecular differences between hypoxic and non-hypoxic tumors within the same patient. A portion of advanced stage EOC are inoperable at diagnosis and can be treated with neoadjuvant chemotherapy (NACT) before surgery. This approach offers a unique opportunity to study how hypoxic tumor areas respond to treatment. |
||||
| Detailed Description |
MORE SPECIFIC AIMS
|
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Device: Imaging with 18F-EF5 PET/CT
Both 18F-FDG PET/CT and 18F-EF5 PET/CT imaging are performed in 1) preoperative work-up to clarify the disease distribution, 2) before IDS to evaluate treatment response to NACT (IDS arm); targeted samples from hypoxic and non-hypoxic tumors are collected during surgery
Other Name: Collection of targeted samples during surgery
|
||||
| Study Arms ICMJE |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE |
40 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | December 31, 2025 | ||||
| Estimated Primary Completion Date | December 31, 2022 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender ICMJE |
|
||||
| Ages ICMJE | 18 Years to 79 Years (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE |
|
||||
| Listed Location Countries ICMJE | Finland | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT04001023 | ||||
| Other Study ID Numbers ICMJE | 15867 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement ICMJE | Not Provided | ||||
| Responsible Party | Turku University Hospital | ||||
| Study Sponsor ICMJE | Turku University Hospital | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE | Not Provided | ||||
| PRS Account | Turku University Hospital | ||||
| Verification Date | August 2019 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||
