Clinical trial · Interventional
Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging
NCT05866679CI-TRIAL-00108417suspendedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Suspension
Summary
Brief summary (as posted)
To learn if an MRSI can be performed on a 3T scanner using an investigational contrast drug called hyperpolarized 13-C pyruvate. 3T refers to the "strength" of the MRI machine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperpolarized 13-C-pyruvate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Hyperpolarized 13-C-pyruvate
- interventionNames
- Drug: Hyperpolarized 13-C-pyruvate
Primary outcomes (1)
- measure
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03
- timeFrame
- through study completion: an average of 5 years
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Months
Show eligibility criteria text
Inclusion Criteria: For the first cohort, the following selection criteria will be applied who are undergoing a screening exam at MD Anderson: 1. Patients with a first degree relative (mother, sister, or daughter) with ovarian cancer or 2. A personal history of breast cancer before age 40 or 3. A personal history of breast cancer diagnosed before age 50, and one or more close relatives diagnosed with breast or ovarian cancer at any age. Two or more close relatives diagnosed with breast cancer before age 50 or with ovarian cancer diagnosed at any age or 4. Ashkenazi Jewish heritage and a personal history of breast cancer before age 50 or 5. Ashkenazi Jewish heritage and a first- or second-degree relative diagnosed with breast cancer before age 50 or with ovarian cancer at any age or 6. Presence of a BRCA1 or BRCA2 mutation or 7. Presence of a mismatch repair gene mutation associated with a hereditary cancer syndrome known as Hereditary Non-Polyposis Colon Cancer (HNPCC)/Lynch syndrome. For the second cohort- 10 Patients will be enrolled who present to MD Anderson for a pelvic ultrasound or have an outside ultrasound or imaging study without a mass or have an adnexal mass (benign) on outside imaging and do not have a high risk for ovarian cancer. For the third cohort of patients: 10 patients who have suspicion of ovarian malignancy on conventional imaging and will be undergoing surgical resection will be included. Exclusion Criteria: (all cohorts) 1\. Children, pregnant women, cognitively impaired adults, or prisoners will be excluded from participation.
References
Publications (0)
Data not yet available
No reference posted for this study.