Lymphatic Mapping for Image Guided Radiotherapy in Patients With LACC - a Feasibility Study

NCT05746156 | Completed DMC

• 1 other identifier: NL9323
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

Lymphatic mapping is a procedure in which all lymph nodes with drainage from the primary tumor, i.e. all nodes with potential (micro)metastases, can be imaged. These nodes are not necessarily suspicious on other imaging techniques. The goal of this feasibility study is to

1. 1.investigate the feasibility of the lymphatic mapping procedure in locally advanced cervical cancer
2. 2.study the agreement of the lymphatic map with the radiotherapy treatment plan including previous imaging (MRI / CT / FDG-PET/CT)

Conditions

Locally Advanced Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• Is it feasible to perform lymphatic mapping in locally advanced cervical cancer? Is there visualisation of (multiple) lymph nodes in both sides of the tumor?

  feasibiliy

  2 years

Secondary Outcomes (1)

• Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?

  2 years

Study Arms (1)

lymphatic map

EXPERIMENTAL

Lymphatic mapping will be performed

Diagnostic Test: lymphatic mapping

Interventions

lymphatic mapping DIAGNOSTIC_TEST

1. Peritumoral injection of \[99mTc\]Tc-nanocolloid in 6-8 evenly distributed depots on both sides of the tumor, during investigation under anaesthesia. Number of depots depending on the size and localisation of the tumor. 2. Planair and SPECT/CT imaging van de abdomen/pelvis 3h and 12-24h after injection at the department of radiology and nucleair medicine.

lymphatic map

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven locally advanced cervical cancer \[FIGO stage IIB-IVA\]. \>18 years old. Treatment with curative (chemo)radiation. Signed informed consent.

You may not qualify if:

• Pregnancy. Administration of the radioactive tracer cannot be ensured properly due to obesity Patients with tumors in which no circumferential injection of \[99mTc\]Tc-nanocolloid is possible due to the size or position of the tumor.

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC University of Amsterdam

Amsterdam, 1100DD, Netherlands

Location

Related Publications (1)

• Adam JA, Poel E, van Eck-Smit BLF, Mom CH, Stalpers LJA, Stoker J, Bipat S. Lymphatic mapping for image-guided radiotherapy in patients with locally advanced uterine cervical cancer: a feasibility study. EJNMMI Res. 2023 Jun 12;13(1):58. doi: 10.1186/s13550-023-00989-0.

  PMID: 37306763 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Results of the lymphatic map will be blinded to the radiation oncologist
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 27, 2023
• Study Start: July 20, 2020
• Primary Completion: July 19, 2022
• Study Completion: July 19, 2022
• Last Updated: February 27, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)