Uterine CancerOvAR-YNCT06904365
Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women
An observational study of Uterine Cancer and Rectal Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
Female patients with early onset (<50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, which often requires pelvic radiation; many of these patients are premenopausal and at a high risk of premature ovarian failure from radiotherapy. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Uterine Cancer, Rectal Cancer, Colon Cancer
- What is being tested?
- HyperSight cone beam computed tomography (CBCT) scan and ETHOS 2.0
- Type of treatment
- Medical device
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2025to 14 Oct 2026
- Phase
- Observational
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: This study will enroll patients at Siteman Cancer Center at Washington University School of Medicine.
Who may be able to join
- Biologic female
- Age between 18 and 50 years old (inclusive)
- Clinically premenopausal (defined as having active, regular menstruation without vasomotor symptoms)
- At least one of two ovaries readily visualized on diagnostic CT or MR imaging as confirmed by radiologist
- Planning to receive radiation therapy (for any indication)
- Ability to understand and willingness to sign an IRB-approved written informed consent document.
Who cannot join
- Prior pelvic radiation
- Prior cancer therapies that are known to impact ovarian function
- Prior diagnosis of ovarian insufficiency/failure or menopause
- Clinically peri- or post-menopausal
- For patients > 45 years old, if there is a clinical history of vasomotor symptoms OR irregular periods, then the patient must be excluded.
- For patients ≤ 45 years old, if there is a history of vasomotor symptoms consistent with menopause OR irregular menstruation for ≥3 months OR recent changes in their menstrual cycle > 14 days, then the patient must be excluded.
- Surgically removed or transposed ovaries
- Pregnant and/or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y): an In-Silico Feasibility Trial
Female patients with early onset (<50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, which often requires pelvic radiation; many of these patients are premenopausal and at a high risk of premature ovarian failure from radiotherapy. Premature ovarian failure carries significant cardiac, musculoskeletal, sexual, and psychosocial morbidity. Ovarian transposition carries variable success rates, is not readily accessible to the general population, and can still be at risk of clinically significant radiotherapy doses. There is an unmet need for innovative techniques to protect ovarian function.
- Conditions
- Uterine Cancer, Rectal Cancer, Colon Cancer, Breast Cancer, Lung Cancer, Sarcoma
- Being tested
- HyperSight cone beam computed tomography (CBCT) scan, ETHOS 2.0
- Keywords
- Young onset colorectal cancer, Early onset, Pre-menopausal, Ovarian sparing radiation
- Medical subject headings
- Uterine Neoplasms, Rectal Neoplasms, Colonic Neoplasms, Breast Neoplasms, Lung Neoplasms, Sarcoma, Uterine Cervical Neoplasms, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HyperSight cone beam computed tomography (CBCT) scanDevice
Also called CBCT
HyperSight is a novel onboard imaging platform with a rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for simulation and treatment.
ETHOS 2.0Device
ETHOS 2.0, an artificial intelligence treatment planning system, will be utilized in an emulator to create SCRT plans to determine the feasibility of clinically significant ovarian dose reductions in-silico.
| Study group | Role | What they receive |
|---|---|---|
| Ovarian-Sparing Adaptive Radiotherapy | A 25 Gy / 5 fx rectal plan for all patients, irrespective of their primary malignancy, will be created as per institutional standards. Patients may undergo treatment on any radiation therapy machine but will have their pelvis images on a HyperSight CBCT machine after consent while they receive their treatment. In general, patients will be imaged with 2 CBCTs approximately 10 minutes apart, each imaging session / day. However, only one CBCT per treatment session is required, and a patient may have between 1 to 10 scans total throughout 1 to 5 imaging sessions. In general, if ovaries are well visualized then only 1 or 2 imaging sessions will be completed. Receives: Device: HyperSight cone beam computed tomography (CBCT) scan; Device: ETHOS 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ovarian visualization
Defined as being able to delineate at least one ovary (if only one is visible, must be the same ovary) for ≥60% of CBCT sessions per patient.
Measured: Estimated to be 5 days
Secondary outcomes (1)
Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose
Defined as maintaining a cumulative >95% coverage of planned tumor volume (PTV) with 95% of the prescription dose (25 Gy/5 fx) while delivering no more 6 Gy to the ovaries per patient. If only one ovary can meet constraints it must be the same ovary over all fractions.
Measured: Estimated to be 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start8 Apr 2025
- Primary completion14 Oct 2026
- Study completion14 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Michael Waters, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06904365
- Sponsor's protocol ID
- 202502088
- Acronym
- OvAR-Y
- Status last verified
- Oct 2026
- First submitted
- 24 Mar 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Data will be shared if research proposal is submitted and approved by Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ovarian-Sparing Adaptive Radiotherapy in Young Adult Women (OvAR-Y): an In-Silico Feasibility Trial
- ClinicalTrials.gov ID
- NCT06904365
- Acronym / sponsor ID
- OvAR-Y / 202502088
- Conditions
- Uterine Cancer, Rectal Cancer, Colon Cancer, Breast Cancer, Lung Cancer, Sarcoma
- Keywords
- Young onset colorectal cancer, Early onset, Pre-menopausal, Ovarian sparing radiation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 14 Oct 2026 (actual)
- Study completion
- 14 Oct 2026 (actual)
- First posted
- 1 Apr 2025 (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.
Female patients with early onset (<50 years old) pelvic malignancies such as uterine and rectal cancers are rising in incidence, which often requires pelvic radiation; many of these patients are premenopausal and at a high risk of premature ovarian failure from radiotherapy. Premature ovarian failure carries significant cardiac, musculoskeletal, sexual, and psychosocial morbidity. Ovarian transposition carries variable success rates, is not readily accessible to the general population, and can still be at risk of clinically significant radiotherapy doses. There is an unmet need for innovative techniques to protect ovarian function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian-Sparing Adaptive Radiotherapy | – | Device: HyperSight cone beam computed tomography (CBCT) scan, Device: ETHOS 2.0A 25 Gy / 5 fx rectal plan for all patients, irrespective of their primary malignancy, will be created as per institutional standards. Patients may undergo treatment on any radiation therapy machine but will have their pelvis images on a HyperSight CBCT machine after consent while they receive their treatment. In general, patients will be imaged with 2 CBCTs approximately 10 minutes apart, each imaging session / day. However, only one CBCT per treatment session is required, and a patient may have between 1 to 10 scans total throughout 1 to 5 imaging sessions. In general, if ovaries are well visualized then only 1 or 2 imaging sessions will be completed. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- This study will enroll patients at Siteman Cancer Center at Washington University School of Medicine.
Key inclusion criteria (6 listed)
- Biologic female
- Age between 18 and 50 years old (inclusive)
- Clinically premenopausal (defined as having active, regular menstruation without vasomotor symptoms)
- At least one of two ovaries readily visualized on diagnostic CT or MR imaging as confirmed by radiologist
- Planning to receive radiation therapy (for any indication)
Key exclusion criteria (8 listed)
- Prior pelvic radiation
- Prior cancer therapies that are known to impact ovarian function
- Prior diagnosis of ovarian insufficiency/failure or menopause
- Clinically peri- or post-menopausal
- Surgically removed or transposed ovaries
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 |
|---|---|---|
| HyperSight cone beam computed tomography (CBCT) scanAlso: CBCTHyperSight is a novel onboard imaging platform with a rapid-acquisition high-quality CBCT imager capable of acquiring images sufficient for simulation and treatment. | Device | Ovarian-Sparing Adaptive Radiotherapy |
| ETHOS 2.0ETHOS 2.0, an artificial intelligence treatment planning system, will be utilized in an emulator to create SCRT plans to determine the feasibility of clinically significant ovarian dose reductions in-silico. | Device | Ovarian-Sparing Adaptive Radiotherapy |
Primary outcome
Incidence of ovarian visualization
Time frame: Estimated to be 5 days
Defined as being able to delineate at least one ovary (if only one is visible, must be the same ovary) for ≥60% of CBCT sessions per patient.
1 secondary outcome
Incidence of dosimetrically sparing one or both ovaries from a functionally ablative radiation dose
Time frame: Estimated to be 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be shared if research proposal is submitted and approved by Principal Investigator.
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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.
Michael Waters, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cancer and Rectal Cancer, run by Washington University School of Medicine at 1 site in United States.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 29 Oct 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ovarian visualization (time frame: Estimated to be 5 days). 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 29 Oct 2026.