## Protocol Section
### Identification Module
**NCT ID:** NCT06419361

**Brief Title:** [68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients

**Official Title:** [68Ga]Ga-Sa-DABI-4 PET Imaging of Stimulator of Interferon Gene Expression in Cancer Patients

#### Organization Study ID Info
**ID:** CYYY-KY-2024-049-01
#### Organization
**Class:** OTHER
**Full Name:** First Affiliated Hospital of Chongqing Medical University
### Status Module
#### Completion Date
**Date:** 2026-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-17

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-14

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-21

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-17
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-14
**Study First Submit QC Date:** 2024-05-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** First Affiliated Hospital of Chongqing Medical University

#### Responsible Party

**Investigator Affiliation:** First Affiliated Hospital of Chongqing Medical University

**Investigator Full Name:** Xiaoyang Zhang

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** Stimulator of interferon gene (STING) protein plays a vital role in the immune surveillance of tumor microenvironment. Monitoring STING expression in tumors benefits the relevant STING therapy. This study will investigate the safety, biodistribution and potential usefulness of a novel 68Ga-labeled agonist (\[68Ga\]Ga-Sa-DABI-4) for noninvasive positron emission tomography (PET) imaging of STING expression in the tumor microenvironment.

### Conditions Module

**Conditions:**

- Stimulator of Interferon Gene

- Cancer

- Positron Emission Tomography

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 30

**Type:** ESTIMATED

**Phases:**

- EARLY_PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients will receive a single administration of \[68Ga\]Ga-Sa-DABI-4.

**Intervention Names:**

- Drug: [68Ga]Ga-Sa-DABI-4

**Label:** [68Ga]Ga-Sa-DABI-4

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- [68Ga]Ga-Sa-DABI-4

**Description:** Each subject receives a single intravenous injection of \[68Ga\]Ga-Sa-DABI-4.

**Name:** [68Ga]Ga-Sa-DABI-4

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The sensitivity, specificity, and accuracy of \[68Ga\]Ga-Sa-DABI-4 PET

**Measure:** Diagnostic efficacy

**Time Frame:** 15 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. At least 18 years of age.
2. Signed informed consent.
3. Patients with suspected or newly diagnosed or previously malignant disease.

Exclusion Criteria:

1. Patients with non-malignant disease.
2. Patients with pregnancy.
3. The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
4. Known or expected hypersensitivity to \[68Ga\]Ga-Sa-DABI-4 or any of its components.
5. Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedures or evaluations of the study.

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhangxy@mail.bnu.edu.cn

**Name:** Xiaoyang Zhang, PhD

**Phone:** 023-89011755

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chongqing

**Country:** China

**Facility:** The First Affiliated Hospital of Chongqing Medical University

**State:** Chongqing

**Zip:** 400016

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10407

- Name: Interferons

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
