Immunological and molecular effects of MR-guided stereotactic radiotherapy in adrenal metastases - A hypothesis generating trial (IM-SABR)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. Have adrenal metastases, for which MR-guided SABR has been recommended
following dis-cussions within a multi-disciplinary tumor board.
2. Be willing and able to provide written informed consent for the trial.
3. Be 18 years of age on day of signing informed consent.

Exclusion Criteria

1. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy
or any other form of immunosuppressive therapy within 30 days prior to the
MR-guided SABR.
2. Has had prior chemotherapy, targeted small molecule therapy, or radiotherapy
within 30 days prior to MR-guided SABR.
3. Has a known additional malignancy that is progressing or requires active
treatment. Exceptions include basal cell carcinoma of the skin, squamous cell
carcinoma of the skin, or in situ cervical cancer that has undergone
potentially curative therapy.
4. Has an active autoimmune disease requiring systemic treatment within the
past 3 months or a syndrome that requires systemic steroids or
immunosuppressive agents. Subjects that require intermittent use of
bronchodilators or local steroid injections would not be excluded from the
study. Subjects with hypothyroidism stable on hormone replacement will not be
excluded from the study.
5. Has an active infection requiring systemic therapy.
6. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the trial, interfere with the
subject*s participation for the full du-ration of the trial, or is not in the
best interest of the subject to participate, in the opinion of the treating
investigator.
7. Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2
antibodies) or a known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C
(e.g., HCV RNA [qualitative] is detected).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameters/endpoints: This hypothesis generating study aims to<br /><br>characterize the immunological effects of different well-tolerated risk-adapted<br /><br>SMART schedules. The primary study endpoints will be the immune responses in<br /><br>the peripheral blood. The endpoints will be assessed by examination liquid<br /><br>biopsies and FACS analysis on peripheral blood to detect immune modulation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p> Secondary endpoints will be local tumor control rates and correlation of<br /><br>measured immune parameters with PTV coverage and rates of tumor regression.</p><br>