## Protocol Section
### Identification Module
**NCT ID:** NCT06417281

**Brief Title:** Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid（5-ALA）

**Official Title:** A Phase III Clinical Trial of Photodynamic Diagnosis for Malignant Brain Glioma With 5-Aminolevulinic Acid

#### Organization Study ID Info
**ID:** F0009-01
#### Organization
**Class:** INDUSTRY
**Full Name:** Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

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

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-12
**Study First Submit QC Date:** 2024-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This trial is an open-label, multicenter, phase III clinical study，conducted in patients with newly diagnosed or recurrent malignant high-grade (WHO grades 3\~4) glioma, to evaluate the efficacy and safety of a single oral dose of 5-aminolevulinic acid (5-ALA) oral solution powder for fluorescence-guided tumor resection and photodynamic diagnosis.

### Conditions Module

**Conditions:**

- 5-aminolevulinic Acid

- Malignant Glioma of Brain

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** DIAGNOSTIC

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** This is an single arm study.

**Intervention Names:**

- Drug: 5 Aminolevulinic Acid

**Label:** 5 Aminolevulinic Acid

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 5 Aminolevulinic Acid

**Description:** 3±1 hours before anesthesia, participants will take 5-ALA orally at a dosage of 20 mg/kg, followed by fluorescence-guided resection of malignant glioma.

**Name:** 5 Aminolevulinic Acid

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The proportion of biopsy tissues diagnosed as malignant glioma cells positive by pathological examination among all tissues collected from both fluorescent and weakly fluorescent areas.

**Measure:** positive predictive rate of tissue fluorescence per biopsy sample taken from fluorescent sites

**Time Frame:** within 48h after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient's written informed consent
* Age 18-75 years
* Radiological suspicion of a malignant glioma
* Indication for surgical tumour resection
* Karnofsky Performance Status (KPS) ≥ 70

Exclusion Criteria:

* Tumor located in the basal ganglia, thalamus, cerebellum, or brainstem
* Porphyria, hypersensitivity to porphyrins，history of cutaneous photosensitivity or photosensitive skin diseases；
* known hypersensitivity to the test drug ingredients
* Any other condition that, in the opinion of the investigator, makes participation in the trial inappropriate;

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** wujinsong@huashan.org.cn

**Name:** jingsong wu, doctor

**Phone:** +8613701707118

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Shanghai

**Contacts:**

***Contact 1:***

- **Name:** jingsong wu, Doctor

- **Role:** CONTACT

**Country:** China

**Facility:** Huashan Hospital, Fudan University

## 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 - Ancestors

- ID: D000017319

- Term: Photosensitizing Agents

- ID: D000003879

- Term: Dermatologic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4107

- Name: Anesthetics

- Relevance: LOW

- As Found: Unknown

- ID: M3960

- Name: Aminolevulinic Acid

- Relevance: HIGH

- As Found: Outcome measures

- ID: M19608

- Name: Photosensitizing Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7074

- Name: Dermatologic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000000622

- Term: Aminolevulinic Acid

### Misc Info Module

- Version Holder: 2024-05-31
