## Protocol Section
### Identification Module
**NCT ID:** NCT06412952

**Brief Title:** 68Ga-NOTA-RM26 PET/CT in Glioma Patients

**Official Title:** 68Ga-NOTA-RM26 PET/CT in Glioma Patients

#### Organization Study ID Info
**ID:** PUMCH-68Ga-RM26 in Glioma
#### Organization
**Class:** OTHER
**Full Name:** Peking Union Medical College Hospital
### Status Module
#### Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-05-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-10-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-26
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Peking Union Medical College Hospital

#### 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 aim of this study was to investigate the value of 68Ga-NOTA-RM26, an antagonist targeting gastrin-releasing peptide receptor (GRPR) PET tracer, in the diagnosis of high WHO grade glioma and prediction the grade of glioma using positron-emission tomography/computed tomography (PET/CT).

**Detailed Description:** The gastrin-releasing peptide receptor (GRPR), also known as bombesin receptor subtype II (BB2), is a member of the G protein-coupled receptor family of bombesin receptors. GRPR is over-expressed in various types of human tumors including breast cancer. RM26, a GRPR antagonist with high affinity, was discovered by peptide backbone modification of bombesin analogues.To target gastrin-releasing peptide receptor in neoplastic cells of human breast cancer, peptide NOTA-RM26 was synthesized with a PEG3 linker between NOTA and RM26, and then labeled with 68Ga. An open-label brain PET/ CT study was designed to assess its clinical diagnostic value in patients with glioma.

### Conditions Module

**Conditions:**

- Glioma

### 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:** Inject 68Ga-Pentixafor and then perform PET/CT scan.

**Intervention Names:**

- Drug: 68Ga-RM26

**Label:** 68Ga-RM26, PET/CT

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 68Ga-RM26, PET/CT

**Description:** Intravenous injection of one dosage of 74-185 MBq(2-5 mCi) 68Ga-RM26. Tracer doses of 68Ga- RM26 will be used to image lesions of glioma by PET/CT.

**Name:** 68Ga-RM26

**Other Names:**

- 68Ga-GRPR antagonist

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** SUVmax of focal lesions are measured on 68Ga-RM26 PET/CT.

**Measure:** SUVmax

**Time Frame:** through study completion, an average of 1.5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* suspected or confirmed untreated glioma patients
* signed written consent.

Exclusion Criteria:

* pregnancy
* breastfeeding
* known allergy against Pentixafor
* any medical condition that in the opinion of the investigator,may
* significantly interfere with study compliance

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 13611093752@163.com

**Name:** Zhaohui Zhu

**Phone:** +8613611093752

**Role:** CONTACT

**Contact 2:**

**Email:** pumch_jacobwong@163.com

**Name:** Rongxi Wang

**Phone:** +8615584172170

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** pumch_jacobwong@163.com

- **Name:** Zhaohui Zhu, MD

- **Phone:** +8619800370331

- **Role:** CONTACT

**Country:** China

**Facility:** Chinese Academy of Medical Science & Peking Union Medical College Hospital

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100730

#### Overall Officials

**Official 1:**

**Affiliation:** Peking Union Medical College Hospital

**Name:** Zhaohui Zhu

**Role:** STUDY_CHAIR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000018302

- Term: Neoplasms, Neuroepithelial

- ID: D000017599

- Term: Neuroectodermal Tumors

- ID: D000009373

- Term: Neoplasms, Germ Cell and Embryonal

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009380

- Term: Neoplasms, Nerve Tissue

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M9020

- Name: Glioma

- Relevance: HIGH

- As Found: Glioma

- ID: M20446

- Name: Neoplasms, Neuroepithelial

- Relevance: LOW

- As Found: Unknown

- ID: M19845

- Name: Neuroectodermal Tumors

- Relevance: LOW

- As Found: Unknown

- ID: M20388

- Name: Neuroectodermal Tumors, Primitive

- Relevance: LOW

- As Found: Unknown

- ID: M12318

- Name: Neoplasms, Germ Cell and Embryonal

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12325

- Name: Neoplasms, Nerve Tissue

- Relevance: LOW

- As Found: Unknown

- ID: T2519

- Name: Glioma

- Relevance: HIGH

- As Found: Glioma

- ID: T4092

- Name: Neuroepithelioma

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000005910

- Term: Glioma

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M261652

- Name: 68Ga-NOTA-RM26

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
