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Ovarian CancerNCT02144311

Benchmarking Intra-tumor Heterogeneity In Ovarian Cancer: Linking In-vivo Imaging Phenotypes With Histology And Genomics

A study testing PET/CT Scan and MRI in people with Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this research study is to learn if differences seen in scans before surgery match differences seen when looking at tumor samples with pathology and genetic tests. In this study we will use Magnetic Resonance Imaging [MRI] and Positron Emission Tomography [PET] scans. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
PET/CT Scan and MRI
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
2 sitesUnited States
Study dates
May 2014to 15 Jun 2020
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age on the day of signing the informed consent.
  • Histologically confirmed or suspected stage III or IV high-grade serous ovarian cancer.
  • Scheduled to undergo primary debulking surgery.

Who cannot join

  • Pregnant patients
  • Patients who because of general medical or psychiatric condition, or physiologic status unrelated to the presence of ovarian cancer cannot give valid informed consent
  • Patients who are unwilling or unable to undergo MRI including patients with contraindications to MRI such as the presence of cardiac pacemakers or non-compatible intracranial vascular clips, claustrophobia, inability to lie flat for the duration of the study etc.
  • Patients with a metallic hip implant or any other metallic implant or device in the pelvis that might distort local magnetic field and compromise quality of MRI/
  • Radiotherapy to the abdomen or pelvis within 6 months of the screening visit. Subjects with a current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas) are not eligible
  • Patients with synchronous primary endometrial cancer or a past history of endometrial cancer, unless all of the following conditions are met:
Show all 16Show fewer
  • Stage not greater than IB
  • No more than superficial myometrial invasion
  • No vascular or lymphatic invasion
  • No poorly differentiated subtypes, including serous, clear cell, or other FIGO Grade 3 lesions.
  • Patients who have received prior chemotherapy for any abdominal or pelvic tumor are excluded. Patients who have received neoadjuvant chemotherapy prior to their initial debulking are excluded. Patients may have received prior adjuvant chemotherapy for breast cancer.
  • With the exception of non-melanoma skin cancer and other specific malignancies as noted above, subjects with other invasive malignancies who had (or have) any evidence of the other cancer present within the last 3 years are excluded.
  • Unresolved bowel obstruction.
  • History or current evidence of any condition, therapy, or lab abnormality that might confound the results of the study, interfere with patient's participation for the full duration of the study.
  • Absence of target lesions (> 2.0 cm) on staging CT
  • Patients unlikely to be optimally debulked at surgery (tumor implants in difficult to reach places [i.e. falciform ligament or porta hepatis], suprarenal retroperitoneal lymphadenopathy)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Memorial Sloan Kettering West Harrison

    Harrison, New York, 10604

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

The purpose of this research study is to learn if differences seen in scans before surgery match differences seen when looking at tumor samples with pathology and genetic tests. In this study we will use Magnetic Resonance Imaging [MRI] and Positron Emission Tomography [PET] scans. No direct clinical benefits will come from the results of this study.

Conditions
Ovarian Cancer
Being tested
PET/CT Scan, MRI
Keywords
MRI, FDG PET/CT, histologic heterogeneity, 14-061
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PET/CT ScanProcedure or surgery

  • MRIProcedure or surgery

Study groups in NCT02144311
Study groupRoleWhat they receive
MRI with DW-MRI & DCE-MRI & FDG PET/CTExperimentalStudy participants will have 1 scan within the 7 days immediately preceding surgery (PET/CT as standard of care and MRI as a research exam). MRI and PET/CT scanning procedures will be identical to those used in routine clinical examinations of the abdomen and pelvis.
Receives: Procedure: PET/CT Scan; Procedure: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Genomic markers of spatial heterogeneity

    by evaluating spatially explicit phenotypic clusters based on a combination of perfusion, diffusion and metabolic tumor profiles (maps) in both ovarian tumors and metastatic peritoneal/omental implants of patients with HGSOC undergoing primary debulking surgery (PDS).

    Measured: 1 year

Secondary outcomes (1)

  1. Histological and immunohistochemical features

    The analyses involving the bioinformatic algorithms will be handled by the Bioinformatics Core. Previously validated bioinformatic algorithms (5, 13, 38) will be used to determine the clonal compositions of the imaging-based phenotypically distinct clusters of HGSOCs, and phylogenetic trees based on allelic frequencies of mutations and copy number aberrations of the primary ovarian tumor and matched metastatic implant will be constructed for each case

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completion15 Jun 2020
  4. Study completion15 Jun 2020

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02144311
Sponsor's protocol ID
14-061
Status last verified
Jun 2020
First submitted
19 May 2014
Last updated
18 Jun 2020
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing PET/CT Scan and MRI in people with Ovarian Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites 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 3 inclusion and 16 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 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Genomic markers of spatial heterogeneity (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02144311.

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 18 Jun 2020.

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