## Protocol Section
### Identification Module
**NCT ID:** NCT05866679

**Brief Title:** Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging

**Official Title:** Early Assessment of Ovarian Cancer Aggressiveness by Metabolic Imaging

#### Organization Study ID Info
**ID:** 2022-0395
#### Organization
**Class:** OTHER
**Full Name:** M.D. Anderson Cancer Center
#### Secondary ID Infos
**Domain:** NCI-Clinical Trials Registry
**ID:** NCI-2023-03931
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2028-08-31

**Type:** ESTIMATED

#### Last Update Post Date
**Date:** 2024-05-02

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-30

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2026-08-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04-12

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2023-05-19
**Type:** ACTUAL
**Study First Submit Date:** 2023-05-10
**Study First Submit QC Date:** 2023-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** M.D. Anderson Cancer Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** 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.

**Detailed Description:** Primary Objective:

1. To assess if increased lactate production measured by HP 13C MRI occurs in suspected ovarian cancer patients who will undergo surgery
2. To evaluate the proportion of increased lactate production in the ovaries measured by HP 13C MRI in low/high ovarian cancer risk patients.

Secondary Objectives:

1. Correlate HP-MR findings to metabolomics, immune profiles, and blood biomarkers of patients undergoing surgical resection.
2. Demonstrate the feasibility and utility of metabolic imaging with HP 13C pyruvate MR in patients with suspected ovarian cancer
3. Correlating imaging findings such as enhancement pattern, ADC values, and advanced image analytics such as texture with pathology and genetic analysis for patients who will undergo surgical resection.

### Conditions Module

**Conditions:**

- Ovarian Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Drug: Hyperpolarized 13-C-pyruvate

**Label:** Hyperpolarized 13-C-pyruvate

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Hyperpolarized 13-C-pyruvate

**Description:** Given by PO

**Name:** Hyperpolarized 13-C-pyruvate

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 4.03

**Time Frame:** through study completion: an average of 5 years

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Months

**Sex:** FEMALE

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** priya.bhosale@mdanderson.org

**Name:** Priya Bhosale, MD

**Phone:** (713) 792-0221

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Houston

**Contacts:**

***Contact 1:***

- **Email:** priya.bhosale@mdanderson.org

- **Name:** Priya Bhosale, MD

- **Phone:** 713-792-0221

- **Role:** CONTACT

***Contact 2:***

- **Name:** Priya Bhosale, Bhosale

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** M D Anderson Cancer Center

**State:** Texas

**Status:** RECRUITING

**Zip:** 77030

#### Overall Officials

**Official 1:**

**Affiliation:** M.D. Anderson Cancer Center

**Name:** Priya Bhosale, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** M D Anderson Cancer Center

**URL:** http://www.mdanderson.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000091662

- Term: Genital Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000096762

- Term: Aberrant Motor Behavior in Dementia

- ID: D000001526

- Term: Behavioral Symptoms

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: M3724

- Name: Aggression

- Relevance: HIGH

- As Found: Aggressiveness

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M6904

- Name: Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M3259

- Name: Aberrant Motor Behavior in Dementia

- Relevance: LOW

- As Found: Unknown

- ID: M4818

- Name: Behavioral Symptoms

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: HIGH

- As Found: Ovarian Cancer

### Condition Browse Module - Meshes

- ID: D000010051

- Term: Ovarian Neoplasms

- ID: D000077216

- Term: Carcinoma, Ovarian Epithelial

- ID: D000000374

- Term: Aggression

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T424

- Name: Pyruvate

- Relevance: HIGH

- As Found: Rapamycin

### Misc Info Module

- Version Holder: 2024-05-24
