## Protocol Section
### Identification Module
**NCT ID:** NCT04246879

**Brief Title:** MRI Following Stereotactic Radiosurgery (SRS) for Brain Metastases

**Official Title:** Diagnostic Accuracy of Delayed MRI Contrast Enhancement Characteristics and Radiation Necrosis Following Stereotactic Radiosurgery (SRS) for Brain Metastases

#### Organization Study ID Info
**ID:** Pro00103163
#### Organization
**Class:** OTHER
**Full Name:** Duke University
### Status Module
#### Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-02

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-01

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-07

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-07-19

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2020-01-29
**Type:** ACTUAL
**Study First Submit Date:** 2020-01-28
**Study First Submit QC Date:** 2020-01-28
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Duke University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to test whether an additional magnetic resonance image (MRI) sequence can improve the ability to distinguish radiation damage from tumor recurrence in participants with brain metastasis who have previously been treated with stereotactic radiosurgery (SRS).

### Conditions Module

**Conditions:**

- Brain Metastases

**Keywords:**

- Laser Interstitial Thermal Therapy (LITT)

- Stereotactic radiosurgery (SRS)

- Magnetic resonance image (MRI)

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 37

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: MRI

**Label:** MRI

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MRI

**Description:** Subjects undergo one additional delayed MRI sequence

**Name:** MRI

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** true tumor will be detected by delayed MRI as determined by biopsy

**Measure:** number of positive MRI sequences along with positive tumor biopsies

**Time Frame:** baseline

**Description:** absence of tumor will be detected by delayed MRI as determined by biopsy

**Measure:** number of negative MRI sequences along with negative tumor biopsies

**Time Frame:** baseline

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adult patients, age ≥18
* Metastatic malignancy with at least 1 brain metastasis previously treated with SRS
* Patients may have also received whole brain radiation therapy (WBRT) for management of brain metastatic disease but this is not required for study participation
* Patients must have been diagnosed with a metastatic solid tumor of any histological type except small cell lung cancer (SCLC), or lymphoma.
* Radiographic progression on post-SRS imaging at previously treated SRS site(s)
* Must be a candidate for brain surgery as determined by treating neurosurgeon and/or anesthesia team
* Patients must sign study-specific informed consent prior to study entry

Exclusion Criteria:

* Poor surgical candidate as determined by treating neurosurgeon and/or anesthesia team
* Unable to undergo contrasted MRI (e.g. incompatible medical device, inadequate renal function per standard institutional clinical protocol, contrast allergy)
* Small cell lung cancer (SCLC) or lymphoma histology

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** eileen.duffy@duke.edu

**Name:** Eileen Duffy, RN OCN

**Phone:** 919 668 3726

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Durham

**Contacts:**

***Contact 1:***

- **Name:** Eileen Duffy, BNS RN OCN

- **Phone:** 919-668-3726

- **Role:** CONTACT

***Contact 2:***

- **Name:** Scott Floyd, MD PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Duke University Health System

**State:** North Carolina

**Status:** RECRUITING

**Zip:** 27710

#### Overall Officials

**Official 1:**

**Affiliation:** Duke Health

**Name:** Scott Floyd, M.D. Ph.D.

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009385

- Term: Neoplastic Processes

- ID: D000009369

- Term: Neoplasms

- ID: D000010335

- Term: Pathologic Processes

- ID: D000016543

- Term: Central Nervous System Neoplasms

- ID: D000009423

- Term: Nervous System Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000001927

- Term: Brain Diseases

- ID: D000002493

- Term: Central Nervous System Diseases

- ID: D000009422

- Term: Nervous System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: HIGH

- As Found: Metastases

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

- ID: M5209

- Name: Brain Neoplasms

- Relevance: HIGH

- As Found: Brain Metastases

- ID: M12330

- Name: Neoplastic Processes

- Relevance: LOW

- As Found: Unknown

- ID: M18937

- Name: Central Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12367

- Name: Nervous System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M5204

- Name: Brain Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M5742

- Name: Central Nervous System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009362

- Term: Neoplasm Metastasis

- ID: D000001932

- Term: Brain Neoplasms

### Misc Info Module

- Version Holder: 2024-05-24
