Is NCT04789486 recruiting in Boston, MA?

Yes, NCT04789486 is currently recruiting participants at its Boston, MA location. This lung cancer clinical trial is actively enrolling qualified participants.

How do I join the lung cancer clinical trial in Boston?

To join this clinical trial in Boston, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Boston clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Lung Cancer Clinical Trial in Boston, MA

About This Lung Cancer Study in Boston

This research study is being done to help determine the safety and efficacy of gadolinium based nanoparticle, Activation and Guidance of Irradiation X (AGuIX), used in conjunction with MR-guided stereotactic body radiation therapy (SBRT) in the treatment of pancreatic cancer and lung tumors.

Sponsor: Dana-Farber Cancer Institute

Who Can Participate

Inclusion Criteria

Patients should have clinical, radiographical, cytological, or histological confirmation of NSCLC or lung or nodal metastases from another primary cancer defined as within or touching the zone of the proximal bronchial tree, defined as a volume 2 cm in all directions around the trachea and proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right and left lower lobe bronchi). Tumors that are immediately adjacent (\<1 cm) to mediastinal or pericardial pleura or other radiation-sensitive organs such as the esophagus and brachial plexus also are considered central tumors and are eligible for this protocol. OR Histologically or cytologically confirmed pancreatic ductal adenocarcinoma of the pancreatic head, body or tail.

Participants must have measurable disease, defined as a lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam. See Section 11 for the evaluation of measurable disease. 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.

Locally advanced, unresectable pancreatic cancer as determined by a pancreaticobiliary surgeon as part of a multidisciplinary discussion at the investigative site, including multi-phasic CT demonstrating tumor abutment of the SMA or celiac axis, SMV or PV involvement which is not resectable without vascular reconstruction.

Completion of at least 3 months of standard induction chemotherapy for LAPC, which should consist of either FOLFIRINOX, gemcitabine and nab-paclitaxel, or another standard combination of induction chemotherapy agent, with a washout period no longer than 10 weeks prior to first dose of study drug.

No evidence of distant metastasis.

Pancreatic or central NSCLC size ≤ 5cm.

Age 18 years or older.

ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).

Ability to understand and follow the breathing instructions involved in the respiratory gating procedure.

Participants must have normal organ and marrow function as defined below:

absolute neutrophil count ≥1,500/mcL

platelets ≥100,000/mcL

total bilirubin within normal institutional limits

AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal

creatinine within normal institutional limits OR

Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above institutional normal.

The effects of AGuIX on the developing human fetus are unknown. For this reason, as well as the known teratogenic effects of radiation, women of child-bearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.

Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Participants who have had prior radiation therapy to the chest or abdomen that would overlap with the current treatment field.

Participants who are receiving any other investigational agents.

Participants with known metastatic disease.

History of allergic reactions attributed to gadolinium-based IV contrast.

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

Pregnant women are excluded from this study because AGuIX is contrast agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with AGuIX, breastfeeding should be discontinued if the mother is treated with AGuIX.

Severe claustrophobia or anxiety.

Known HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with AGuIX. In addition, these participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.

Active duodenal or gastric ulcer disease or evidence of tumor invasion of the bowel or stomach based on endoscopy.

Presence of a duodenal stent.

Unable to undergo magnetic resonance imaging (MRI) due to any of the following:

Presence of MRI-incompatible metal material or devices in the human body

MRI-incompatible Pacemaker or defibrillator

Insulin pump

Aneurysm clip

Artificial heart valve

Cochlear implant

Shrapnel or gunshot injury

Cataract surgery with implant unsafe for MRI

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Boston?

Yes, this clinical trial (NCT04789486) has an active research site in Boston, MA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Lung Cancer Treatment Options in Boston, MA

If you're searching for lung cancer treatment options in Boston, MA, this clinical trial (NCT04789486) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Boston research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced lung cancer specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all lung cancer clinical trials near you to find additional studies recruiting in your area.

Lung Cancer Clinical Trial in Boston, MA

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