Locally Advanced Cervical CancerLaMANCT05746156
Lymphatic Mapping for Image Guided Radiotherapy in Patients With LACC - a Feasibility Study
A study testing lymphatic mapping in people with Locally Advanced Cervical Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Locally Advanced Cervical Cancer
- What is being tested?
- lymphatic mapping
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- 20 Jul 2020to 19 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically proven locally advanced cervical cancer [FIGO stage IIB-IVA]. >18 years old. Treatment with curative (chemo)radiation. Signed informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- 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)
Read the 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?
- Conditions
- Locally Advanced Cervical Cancer
- Being tested
- lymphatic mapping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lymphatic mappingDiagnostic test
- 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.
| Study group | Role | What they receive |
|---|---|---|
| lymphatic map | Experimental | Lymphatic mapping will be performed Receives: Diagnostic Test: lymphatic mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?
comparison to RT treatment plan
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start20 Jul 2020
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced Cervical CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Shandra Bipat PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746156
- Sponsor's protocol ID
- NL9323
- Acronym
- LaMA
- Status last verified
- Feb 2023
- First submitted
- 17 Feb 2023
- Last updated
- 27 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37306763
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphatic Mapping for Image Guided Radiotherapy in Patients With Locally Advanced Cervical Cancer, a Feasibility Study
- ClinicalTrials.gov ID
- NCT05746156
- Acronym / sponsor ID
- LaMA / NL9323
- Conditions
- Locally Advanced Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lymphatic map | Experimental | Diagnostic Test: lymphatic mappingLymphatic mapping will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Histologically proven locally advanced cervical cancer [FIGO stage IIB-IVA]. >18 years old. Treatment with curative (chemo)radiation. Signed informed consent.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lymphatic mapping1. 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. | Diagnostic test | lymphatic map |
Primary outcome
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?
Time frame: 2 years
feasibiliy
1 secondary outcome
Are all visible lymph nodes (nodes at risk) included in the standard radiotherapy treatment plan?
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2023.
- Derived from this study: PubMed 37306763Adam 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lymphatic mapping in people with Locally Advanced Cervical Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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? (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05746156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2023.