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

Primary Purpose

Locally Advanced Cervical Cancer

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
lymphatic mapping
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Locally Advanced Cervical Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Amsterdam UMC University of Amsterdam

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

lymphatic map

Arm Description

Lymphatic mapping will be performed

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 17, 2023
Last Updated
February 17, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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1. Study Identification

Unique Protocol Identification Number
NCT05746156
Brief Title
Lymphatic Mapping for Image Guided Radiotherapy in Patients With LACC - a Feasibility Study
Acronym
LaMA
Official Title
Lymphatic Mapping for Image Guided Radiotherapy in Patients With Locally Advanced Cervical Cancer, a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
July 19, 2022 (Actual)
Study Completion Date
July 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 investigate the feasibility of the lymphatic mapping procedure in locally advanced cervical cancer study the agreement of the lymphatic map with the radiotherapy treatment plan including previous imaging (MRI / CT / FDG-PET/CT)
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: 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? Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Cervical Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Results of the lymphatic map will be blinded to the radiation oncologist
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lymphatic map
Arm Type
Experimental
Arm Description
Lymphatic mapping will be performed
Intervention Type
Diagnostic Test
Intervention Name(s)
lymphatic mapping
Intervention Description
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.
Primary Outcome Measure Information:
Title
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?
Description
feasibiliy
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?
Description
comparison to RT treatment plan
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Amsterdam UMC University of Amsterdam
City
Amsterdam
ZIP/Postal Code
1100DD
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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