Gastric AdenocarcinomaPhase 1NCT05038098
Magnetic Sentinel Lymph Node Mapping in Gastric Cancer
A Phase 1 study testing Gastrectomy, Indocyanine Green and Iron Conjugated Polymers in Saline Suspension in people with Gastric Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase I finds out the possible benefits and/or side effects of using magnetic tracer FerroTrace and the fluorescent dye indocyanine green to identify the lymph nodes that cancer is most likely to have spread to in patients with gastric cancer that are undergoing gastrectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Adenocarcinoma
- What is being tested?
- Gastrectomy, Indocyanine Green and Iron Conjugated Polymers in Saline Suspension
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2026to 2 Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Willing to provide informed consent
- Biopsy proven gastric cancer, undergoing curative-intent gastrectomy
- No distant metastases
- Pathologic diagnosis of gastric adenocarcinoma
- Pre-treatment endoscopic measurement of less than or equal to 4 cm in diameter of the gastric cancer
Who cannot join
- Contraindications to surgery +/- adjuvant therapy
- Allergy or intolerance to iron oxide compounds
- Allergy or intolerance to iodides
- Iron overload disorder
- Pregnant or lactating women*
- Use of contraception is required for females during the study. Male patients who are sexually active with a female of childbearing potential are allowed for study enrollment and will not require use of contraception
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
M D Anderson Cancer Center
Houston, Texas, 77030
Naruhiko Ikoma, 713-792-6940, nikoma@mdanderson.org
Naruhiko Ikoma
About this study
Official title: Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial
This phase I finds out the possible benefits and/or side effects of using magnetic tracer FerroTrace and the fluorescent dye indocyanine green to identify the lymph nodes that cancer is most likely to have spread to in patients with gastric cancer that are undergoing gastrectomy. Using FerroTrace in combination with the indocyanine green dye may help researchers better detect the disease.
Read the detailed description
PRIMARY OBJECTIVE:
- To assess safety by assessing short term toxicity associated with the gastric injection of the novel magnetic tracer.
SECONDARY OBJECTIVES:
- To determine the feasibility of sentinel lymph node (SLN) imaging and mapping using novel magnetic nanoparticles (iron conjugated polymers in saline suspension [FerroTrace]) for gastric cancer, and to determine whether pre-operative injection, intra-operative injection, or both are feasible.
II. To test the validity of this procedure by correlating sentinel lymph nodes (SLN) to predict pathologic Lymph node (LN)-positive status i.e., will a negative SLN accurately predict the negativity of the other LNs? III. To determine the diagnostic value of additional hematoxylin and eosin (H\&E) sections and immunohistochemistry to assess sentinel lymph nodes compared to routine assessment with one H\&E stain alone.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I (PREOPERATIVE INJECTION): Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive indocyanine green (ICG) peritumorally.
COHORT II (INTRAOPERATIVE INJECTION): Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.
- Conditions
- Gastric Adenocarcinoma
- Being tested
- Gastrectomy, Indocyanine Green, Iron Conjugated Polymers in Saline Suspension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastrectomyProcedure or surgery
Also called Gastric Resection
Undergo surgery
Indocyanine GreenDrug
Also called ICG
Given peritumorally
Iron Conjugated Polymers in Saline SuspensionOther
Also called FerroTrace
Given peritumorally
| Study group | Role | What they receive |
|---|---|---|
| Cohort I (preoperative injection) | Experimental | Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally. Receives: Procedure: Gastrectomy; Drug: Indocyanine Green; Other: Iron Conjugated Polymers in Saline Suspension |
| Cohort II (intraoperative) | Experimental | Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery. Receives: Procedure: Gastrectomy; Drug: Indocyanine Green; Other: Iron Conjugated Polymers in Saline Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of endoscopic peritumoral gastric injection of FerroTrace
The Bayesian method by Thall et al. will be applied for interim toxicity monitoring. Toxicities are defined as any grade III or greater toxicities attributable to FerroTrace injection, which occur within 24 hours of the injection. Will summarize the rate of adverse events (AEs) in all patients and by cohort, along with the exact 95% confidence interval.
Measured: Within 24 hours of the FerroTrace injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start31 Dec 2026 (estimated)
- Primary completion2 Feb 2027 (estimated)
- Study completion2 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Naruhiko Ikoma, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038098
- Sponsor's protocol ID
- 2021-0410
- Other IDs
- NCI-2021-08919, 2021-0410
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2021
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Sentinel Lymph Node Mapping in Gastric Cancer, Safety and Feasibility Clinical Trial
- ClinicalTrials.gov ID
- NCT05038098
- Acronym / sponsor ID
- 2021-0410
- Conditions
- Gastric Adenocarcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 31 Dec 2026 (estimated)
- Primary completion
- 2 Feb 2027 (estimated)
- Study completion
- 2 Feb 2027 (estimated)
- First posted
- 8 Sep 2021 (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.
This phase I finds out the possible benefits and/or side effects of using magnetic tracer FerroTrace and the fluorescent dye indocyanine green to identify the lymph nodes that cancer is most likely to have spread to in patients with gastric cancer that are undergoing gastrectomy. Using FerroTrace in combination with the indocyanine green dye may help researchers better detect the disease.
Detailed description
PRIMARY OBJECTIVE:
- To assess safety by assessing short term toxicity associated with the gastric injection of the novel magnetic tracer.
SECONDARY OBJECTIVES:
- To determine the feasibility of sentinel lymph node (SLN) imaging and mapping using novel magnetic nanoparticles (iron conjugated polymers in saline suspension [FerroTrace]) for gastric cancer, and to determine whether pre-operative injection, intra-operative injection, or both are feasible.
II. To test the validity of this procedure by correlating sentinel lymph nodes (SLN) to predict pathologic Lymph node (LN)-positive status i.e., will a negative SLN accurately predict the negativity of the other LNs? III. To determine the diagnostic value of additional hematoxylin and eosin (H\&E) sections and immunohistochemistry to assess sentinel lymph nodes compared to routine assessment with one H\&E stain alone.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT I (PREOPERATIVE INJECTION): Patients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive indocyanine green (ICG) peritumorally.
COHORT II (INTRAOPERATIVE INJECTION): Patients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort I (preoperative injection) | Experimental | Procedure: Gastrectomy, Drug: Indocyanine Green, Other: Iron Conjugated Polymers in Saline SuspensionPatients receive FerroTrace peritumorally within days 1-21. Patients then undergo gastrectomy and receive ICG peritumorally. |
| Cohort II (intraoperative) | Experimental | Procedure: Gastrectomy, Drug: Indocyanine Green, Other: Iron Conjugated Polymers in Saline SuspensionPatients undergo gastrectomy and receive FerroTrace and ICG peritumorally during surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Willing to provide informed consent
- Biopsy proven gastric cancer, undergoing curative-intent gastrectomy
- No distant metastases
- Pathologic diagnosis of gastric adenocarcinoma
Key exclusion criteria (6 listed)
- Contraindications to surgery +/- adjuvant therapy
- Allergy or intolerance to iron oxide compounds
- Allergy or intolerance to iodides
- Iron overload disorder
- Pregnant or lactating women*
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 |
|---|---|---|
| GastrectomyAlso: Gastric ResectionUndergo surgery | Procedure or surgery | Cohort I (preoperative injection), Cohort II (intraoperative) |
| Indocyanine GreenAlso: ICGGiven peritumorally | Drug | Cohort I (preoperative injection), Cohort II (intraoperative) |
| Iron Conjugated Polymers in Saline SuspensionAlso: FerroTraceGiven peritumorally | Other | Cohort I (preoperative injection), Cohort II (intraoperative) |
Primary outcome
Safety of endoscopic peritumoral gastric injection of FerroTrace
Time frame: Within 24 hours of the FerroTrace injection
The Bayesian method by Thall et al. will be applied for interim toxicity monitoring. Toxicities are defined as any grade III or greater toxicities attributable to FerroTrace injection, which occur within 24 hours of the injection. Will summarize the rate of adverse events (AEs) in all patients and by cohort, along with the exact 95% confidence interval.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
Naruhiko Ikoma principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Gastrectomy, Indocyanine Green and Iron Conjugated Polymers in Saline Suspension in people with Gastric Adenocarcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.
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 6 inclusion and 6 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: opening soon, as of the sponsor's last update on 14 Aug 2026. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naruhiko Ikoma, MD (832-729-2675, nikoma@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of endoscopic peritumoral gastric injection of FerroTrace (time frame: Within 24 hours of the FerroTrace injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Aug 2026.