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A Single-Center, Single-Arm Clinical Trial on the Efficacy and Safety of 5-Aminolevulinic Acid Hydrochloride (5-ALA) for Sentinel Lymph Node Tracing in Cervical Metastasis of Oral Cancer

A Single-Center, Single-Arm Clinical Trial on the Efficacy and Safety of 5-Aminolevulinic Acid Hydrochloride (5-ALA) for Sentinel Lymph Node Tracing in Cervical Metastasis of Oral Cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108858
Enrollment
Unknown
Registered
2025-09-08
Start date
2025-09-08
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

oral cancer

Interventions

Test group:Tracing metastatic lymph nodes using 5-ALA in oral cancer patients

Sponsors

Peking University Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 65 years. 2. Histopathologically confirmed squamous cell carcinoma preoperatively. 3. Clinical N stage of cN1–3: presence of suspicious lymph node metastasis on clinical examination and imaging.

Exclusion criteria

Exclusion criteria: 1. History of drug allergy or atopic constitution. 2. Previous history of oral tumor, neck surgery, or radiochemotherapy. 3. Patients with abnormal hepatic or renal function. 4. History of gastrointestinal ulcer or bleeding. 5. History of dermatological diseases. 6. Other conditions deemed by the investigator to render the patient unsuitable for participation.

Design outcomes

Primary

MeasureTime frame
Sensitivity;—

Secondary

MeasureTime frame
Drug-related reactions;Specificity;Negative predictive value;—

Countries

China

Contacts

Public ContactXiaofeng Shan

Peking University Hospital of Stomatology

kqsxf@263.net+86 10 8219 5158

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026