Epithelial Ovarian CancerOVANOXNCT04001023
Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia
A study testing Imaging with 18F-EF5 PET/CT in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Turku University Hospital at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 79 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma
- What is being tested?
- Imaging with 18F-EF5 PET/CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFinland
- Study dates
- 9 Mar 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- newly diagnosed advanced epithelial ovarian, primary peritoneal or fallopian tube cancer.
- age 18-79 years
- informed concent
Who cannot join
- previous cancer
- pregnancy or nursing
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku University hospital
Turku, 20521
Sakari Hietanen, MD, PhD, Adj. prof, +35823130000, sakari.hietanen@tyks.fi
Johanna Hynninen, MD, PhD
About this study
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.
Read the 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)
- Being tested
- Imaging with 18F-EF5 PET/CT
- Keywords
- advanced ovarian cancer, EF5-PET/CT, hypoxia
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imaging with 18F-EF5 PET/CTDevice
Also called Collection of targeted samples during surgery
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
| Study group | Role | What they receive |
|---|---|---|
| PDS | Experimental | 18F-EF5 PET/CT and 18F-FDG PET/CT scan prior to primary cytoreductive surgery and targeted sample collection during primary cytoreductive surgery Receives: Device: Imaging with 18F-EF5 PET/CT |
| IDS | Experimental | 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 Receives: Device: Imaging with 18F-EF5 PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
18F-EF5 maximum standardized uptake values (SUVmax)
Tumor and musculus gluteus maximus SUVmax ratio ≥1.5 is considered to refer to hypoxia
Measured: 2-3 years
Secondary outcomes (3)
Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue
Measured: 2-3 years
Disease-free survival
Measured: 5 years
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start9 Mar 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04001023
- Sponsor's protocol ID
- 15867
- Acronym
- OVANOX
- Status last verified
- Aug 2019
- First submitted
- 11 Jan 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia
- ClinicalTrials.gov ID
- NCT04001023
- Acronym / sponsor ID
- OVANOX / 15867
- Keywords
- advanced ovarian cancer, EF5-PET/CT, hypoxia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PDS | Experimental | Device: Imaging with 18F-EF5 PET/CT18F-EF5 PET/CT and 18F-FDG PET/CT scan prior to primary cytoreductive surgery and targeted sample collection during primary cytoreductive surgery |
| IDS | Experimental | Device: Imaging with 18F-EF5 PET/CT18F-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 |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- newly diagnosed advanced epithelial ovarian, primary peritoneal or fallopian tube cancer.
- age 18-79 years
- informed concent
Key exclusion criteria (2 listed)
- previous cancer
- pregnancy or nursing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Imaging with 18F-EF5 PET/CTAlso: Collection of targeted samples during surgeryBoth 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 | Device | IDS, PDS |
Primary outcome
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
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imaging with 18F-EF5 PET/CT in people with Epithelial Ovarian Cancer and Fallopian Tube Cancer, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maren Laasik, MD (+35823130000, maren.laasik@utu.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
18F-EF5 maximum standardized uptake values (SUVmax) (time frame: 2-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.