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

Lymphatic Mapping for Image Guided Radiotherapy in Patients With Locally Advanced Cervical Cancer, a Feasibility Study

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

Study Overview

• Status: Completed
• Conditions: Locally Advanced Cervical Cancer
• Intervention / Treatment: Diagnostic test: lymphatic mapping

Detailed Description

Study population:

Aged ≥18 years, with locally advanced cervical cancer, that will be planned for radiotherapy.

Intervention (if applicable): Lymphatic mapping will be performed on all study patients during the standard investigation under anaesthesia, to ensure painless injection of the radiopharmaceutical. Patients will receive 6-8 depots of [99mTc]Tc-nanocolloid peritumoral. Planar and SPECT/CT gamma camera images will be made at the department of Radiology and Nuclear medicine 3 hours and 12-24 hours after administration of the radiopharmaceutical. All radioactive lymph nodes will be included in the lymphatic map.

The radiation oncologist will determine the radiation therapy treatment plan blinded to the data of the lymphatic mapping. The lymphatic map will be compared to the radiation treatment plan and previous imaging (MRI / CT / FDG-PET/CT).

Main study parameters/endpoints:

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

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands, 1100DD
    • Amsterdam UMC University of Amsterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lymphatic map; Lymphatic mapping will be performed	Diagnostic test: lymphatic mapping; 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.; Planair and SPECT/CT imaging van de abdomen/pelvis 3h and 12-24h after injection at the department of radiology and nucleair medicine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?	comparison to RT treatment plan	2 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): July 19, 2022
• Study Completion (Actual): July 19, 2022

Study Registration Dates

• First Submitted: February 17, 2023
• First Submitted That Met QC Criteria: February 17, 2023
• First Posted (Estimate): February 27, 2023

Study Record Updates

• Last Update Posted (Estimate): February 27, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: NL9323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No