Aminolevulinic Acid

Generic Name: Aminolevulinic Acid

Brand Names: Ameluz, Gliolan, Levulan

Drug Type: Small Molecule

Chemical Formula: C_₅H_₉NO_₃

CAS Number: 106-60-5

Unique Ingredient Identifier: 88755TAZ87

Background: A compound produced from succinyl-CoA and glycine as an intermediate in heme synthesis. It is used as a photochemotherapy for actinic keratosis. [PubChem]

Indication: 用于皮肤癌及鲍温病、牛皮癣，男性尿道尖锐湿疣等皮肤病。可治疗消化道肿瘤、口腔癌。可诊断和治疗膀胱癌、尿路上皮肿瘤。能阻止血管成形术后在狭窄。

Associated Conditions: Actinic Cheilitis, Actinic Keratoses of the face, Actinic Keratoses of the scalp, Actinic Keratosis (AK) of the Upper Extremity, Basal Cell Carcinoma (BCC), Cutaneous Squamous Cell Carcinoma in Situ (CSCCis), Glioma

Associated Therapies: -

Clinical Trials

Fluorescence Image Guided Surgery Followed by Intraoperative Photodynamic Therapy for Improving Local Tumor Control in Patients With Locally Advanced or Recurrent Colorectal Cancer

Phase 1

Recruiting

Conditions: Stage III Colorectal Cancer
Locally Advanced Colorectal Carcinoma
Recurrent Colorectal Carcinoma

Interventions: Drug: Aminolevulinic Acid
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Fluorescence-Guided Surgery
Procedure: Magnetic Resonance Imaging
Drug: Photodynamic Therapy
Procedure: Surgical Procedure

First Posted Date: 2024-03-13

Last Posted Date: 2024-08-05

Lead Sponsor: Roswell Park Cancer Institute

Target Recruit Count: 21

Registration Number: NCT06307548

Locations: 🇺🇸
Roswell Park Cancer Institute, Buffalo, New York, United States

Fluorescent Aided Resection and Evaluation of Soft Tissue Sarcomas (FLARES)

Phase 1

Withdrawn

Conditions: Soft Tissue Sarcoma
Soft Tissue Sarcoma Adult

Interventions: Drug: Aminolevulinic Acid

First Posted Date: 2024-02-12

Last Posted Date: 2024-08-15

Lead Sponsor: University of California, Davis

Registration Number: NCT06252727

Locations: 🇺🇸
University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

Phase III Clinical Trial Evaluating the Efficacy and Safety of 5-aminolevulinic Acid (5-ALA）

Phase 3

Not yet recruiting

Conditions: Fluorescence-guided Resection
5-aminolevulinic Acid

Interventions: Drug: 5-aminolevulinic acid

First Posted Date: 2023-12-07

Last Posted Date: 2023-12-08

Lead Sponsor: Lee's Pharmaceutical Limited

Target Recruit Count: 144

Registration Number: NCT06160492

Locations: 🇨🇳
Sun Yat-Sen University Cancer Center, Guangzhou, Guangdong, China

Sonodynamic Therapy with ExAblate System in Glioblastoma Patients

Phase 2

Completed

Conditions: Glioblastoma Multiforme

Interventions: Drug: 5-Aminolevulinic Acid

First Posted Date: 2021-04-15

Last Posted Date: 2024-11-11

Lead Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Target Recruit Count: 5

Registration Number: NCT04845919

Locations: 🇮🇹
Foundation IRCCS Carlo Besta Neurological Institute, Milan, Italy

A Pilot Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Pituitary Adenomas

Conditions: Pituitary Adenoma

First Posted Date: 2020-05-18

Last Posted Date: 2021-02-24

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 40

Registration Number: NCT04390802

Phase I Study in Advanced Malignancies With 5-ALA

Phase 1

Recruiting

Conditions: Solid Tumor

Interventions: Drug: 5-ALA

First Posted Date: 2020-05-11

Last Posted Date: 2024-08-26

Lead Sponsor: Fox Chase Cancer Center

Target Recruit Count: 130

Registration Number: NCT04381806

Locations: 🇺🇸
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States

Extracorporeal Photopheresis of Patients With Crohn's Disease Using 5-aminolevulinic Acid

Phase 1

Completed

Conditions: Crohn Disease

Interventions: Drug: 5-aminolevulinic acid
Procedure: Blue light photopheresis
Procedure: Transfusion
Procedure: Continuous Mononuclear Cell Collection (CMNC)

First Posted Date: 2019-11-15

Last Posted Date: 2024-01-30

Lead Sponsor: University Hospital, Akershus

Target Recruit Count: 7

Registration Number: NCT04164849

Locations: 🇳🇴
Akershus University Hospital, Lorenskog, Akershus, Norway

Novel Exoscope System for 5-ALA Fluorescence-Guided Surgery for Gliomas

Completed

Conditions: Glioma
Brain Tumor

Interventions: Device: Orbeye surgical videomicroscope
Drug: 5-Aminolevulinic Acid

First Posted Date: 2019-08-14

Last Posted Date: 2022-05-31

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 20

Registration Number: NCT04055688

Locations: 🇺🇸
H. Lee Moffitt Cancer and Research Institute, Tampa, Florida, United States

PD L 506 for Stereotactic Interstitial Photodynamic Therapy of Newly Diagnosed Supratentorial IDH Wild-type Glioblastoma

Phase 2

Recruiting

Conditions: Glioblastoma

Interventions: Drug: 5-aminolevulinic acid

First Posted Date: 2019-04-01

Last Posted Date: 2023-11-18

Lead Sponsor: photonamic GmbH & Co. KG

Target Recruit Count: 20

Registration Number: NCT03897491

Locations: 🇩🇪
Klinikum der Universität München, München, Germany
🇩🇪
Uniklinik Köln, Köln, Germany
🇩🇪
Universitätsklinikum Münster, Münster, Germany

Study of Daylight Photodynamic Therapy With Aminolevulinic Acid for Actinic Keratoses

Phase 4

Completed

Conditions: Actinic Keratosis

Interventions: Drug: Aminolevulinic Acid

First Posted Date: 2017-10-31

Last Posted Date: 2024-06-27

Lead Sponsor: University of California, Irvine

Target Recruit Count: 30

Registration Number: NCT03327831

Locations: 🇺🇸
University of California, Irvine, Irvine, California, United States

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