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
About this trial
This is an interventional diagnostic trial for Locally Advanced Cervical Cancer
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.
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
NCT ID
NCT05746156
First Posted
February 17, 2023
Last Updated
February 17, 2023
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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
We'll reach out to this number within 24 hrs