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Nanoparticle

Nanoparticle-Enhanced Radiotherapy for Pancreatic Cancer

Phase 1 & 2
Recruiting
Led By Daniel Cagney, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤2
Eligible NSCLC patients must have no evidence of nodal involvement (N0), and disease has to be determined unresectable by a thoracic oncologist or the patient is medically inoperable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through study completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing a new cancer treatment that combines a nanoparticle with radiation. They want to see if it's effective and safe for treating pancreatic cancer and lung tumors.

Who is the study for?
This trial is for adults with certain types of lung or pancreatic cancer that can't be removed by surgery. Participants must have completed standard chemotherapy if they have pancreatic cancer, and their tumors should be no larger than 5cm. They need to have normal organ function, no distant metastasis, and an ECOG performance status ≤2 (which means they are able to walk and do some activities).Check my eligibility
What is being tested?
The study tests a new treatment combining AGuIX nanoparticles with MR-guided stereotactic body radiation therapy (SBRT) for treating non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma. The goal is to see how safe this combination is and how well it works against these cancers.See study design
What are the potential side effects?
Potential side effects may include reactions related to the gadolinium-based nanoparticles such as allergic responses or toxicity affecting organs. Side effects from radiotherapy might involve skin changes, fatigue, nausea, or inflammation in treated areas.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My lung cancer has not spread to my lymph nodes and cannot be removed by surgery.
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My cancer has not spread to distant parts of my body.
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My organ and bone marrow functions are normal.
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My cancer is a confirmed type of pancreatic cancer.
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I am 18 years old or older.
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My pancreatic cancer cannot be removed by surgery.
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My lung cancer or cancer spread to lungs is confirmed by tests.
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I have completed 3 months of initial chemotherapy for advanced pancreatic cancer.
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My lung or pancreatic cancer is 5cm or smaller.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare Local Control at 12 months of Maximum tolerated dose MTD - Phase 2
Maximum tolerated dose (MTD) Phase 1
Secondary outcome measures
Compare disease-specific survival
Compare overall survival
Overall Response Rate (ORR) at Maximum tolerated dose (MTD)
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: SMART Phase 2Experimental Treatment1 Intervention
Randomized participants will receive standard of care SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT).
Group II: AGUIX + SMART Phase 2Experimental Treatment2 Interventions
Randomized participants will receive recommended phase 1 dose established for their disease group (central lung tumor or locally advanced/unresectable pancreatic ductal adenocarcinoma-LAPC) of Activation and Guidance of Irradiation X (AGUIX) and SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT).
Group III: AGUIX + SMART Phase 1Experimental Treatment2 Interventions
Dose escalation of Activation and Guidance of Irradiation X (AGUIX) and SMART, magnetic resonance imaging (MR)-guided stereotactic body radiation therapy (SBRT). Central lung tumor cohort will receive: five fractions of stereotactic body radiation therapy (SBRT) AGuIX Nanoparticle given on -7 or -14 day prior to radiation treatment, then with 1st fraction of radiation and for patients receiving radiation over a two (2) week period with the 4th fraction of radiation . Locally advanced/unresectable pancreatic ductal adenocarcinoma-LAPC cohort, will receive: five fractions of stereotactic body radiation therapy (SBRT) AGuIX Nanoparticle given on -7 or -14 day prior to radiation treatment, then with 1st fraction of radiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AGuIX
2016
Completed Phase 1
~20
Radiotherapy
2017
Completed Phase 3
~2610

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,077 Previous Clinical Trials
340,643 Total Patients Enrolled
NH TherAguix SASOTHER
3 Previous Clinical Trials
249 Total Patients Enrolled
Daniel Cagney, MDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

AGuIX (Nanoparticle) Clinical Trial Eligibility Overview. Trial Name: NCT04789486 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: SMART Phase 2, AGUIX + SMART Phase 1, AGUIX + SMART Phase 2
Non-Small Cell Lung Cancer Clinical Trial 2023: AGuIX Highlights & Side Effects. Trial Name: NCT04789486 — Phase 1 & 2
AGuIX (Nanoparticle) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04789486 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still places available for participants in this research?

"The clinical trial mentioned is still actively recruiting patients, with the most recent update being on October 31st, 2022. This information was first reported on May 27th, 2021."

Answered by AI

What are researchers trying to learn from this clinical trial?

"The assessors of this study will monitor patients for 12 months to determine the maximum tolerated dose (MTD). Additionally, they will compare the R0 resection rate, serious adverse events at 12 months, and overall survival rate."

Answered by AI

How many people fit the bill for this clinical trial's requirements?

"That is accurate. The clinicaltrials.gov website provides evidence that this trial, which was originally posted on May 27th 2021, 100 patients from 3 locations."

Answered by AI
~41 spots leftby Apr 2026